Positive Opinion Recommends Approval of the First and Only Anti-TNF Therapy in Pediatric Patients with Severely Active Ulcerative Colitis, a Chronic, Inflammatory Bowel Disease
WHITEHOUSE STATION, NJ, USA I January 20, 2012 I MSD (also known as Merck in the United States and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the use of REMICADE® (infliximab) in the treatment of severely active ulcerative colitis (UC) in pediatric patients ages 6 to 17 years, who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. REMICADE, a monoclonal antibody that specifically targets tumor necrosis factor (TNF)-alpha, was approved in the European Union (EU) in March 2006 for the treatment of moderately to severely active UC in adults. REMICADE has been used in the treatment of inflammatory bowel disease (IBD) for more than 12 years in the EU, having been first approved for severely active Crohn’s disease in adults in 1999, and more recently, moderately to severely active pediatric Crohn’s disease in 2007.
Upon receipt of the corresponding Commission Decision, REMICADE will be the first and only biologic therapy approved in the EU for the treatment of pediatric UC, a debilitating condition that causes inflammation and painful swelling of the inner lining of the large intestine.
“For parents of children who suffer from the sometimes devastating effects of ulcerative colitis, the positive opinion adopted by the CHMP is encouraging news and a significant step towards making REMICADE available to a younger patient population in Europe,” said Rupert Vessey, MRCP, DPhil, Senior Vice President, Research Laboratories, Merck. “Building on our long heritage in immunology, today’s positive opinion further reinforces the efficacy of REMICADE in the treatment of inflammatory bowel disease and our commitment to expanding treatment options for patients in Europe.”
The CHMP adopted their opinion based on a review of data from a Phase 3 multicenter, randomized, open-label, parallel-group clinical study that assessed the efficacy and safety of REMICADE in 60 pediatric patients ages 6 through 17 years diagnosed with moderately to severely active ulcerative colitis who had experienced an inadequate response to conventional therapies. Findings from the 54-week study showed the efficacy of REMICADE in this pediatric population.
A final decision from the European Commission is expected during the first quarter of 2012.
Janssen Biotech, Inc. discovered and developed REMICADE and markets the product in the United States. The Janssen Pharmaceutical Companies market REMICADE in Canada, Central and South America, the Middle East, Africa and Asia Pacific.
In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to REMICADE to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc.
About Pediatric Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowl disease that causes inflammation, or painful swelling, of the colon mucosa, or innermost lining of the large intestine. Symptoms typically include bloody stools, severe diarrhea and frequent abdominal pain, which often impacts school and social activities. Children with pediatric ulcerative colitis may also experience delayed growth. Although ulcerative colitis may occur at any pediatric age, it is most often diagnosed in early adolescence and affects males and females equally. While long periods of remission are possible, children with ulcerative colitis typically must mange the disease the rest of their lives.
About Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease affecting more than 700,000 people in the European Union. It is marked by the inflammation and ulceration of the colon mucosa, or innermost lining, which causes bloody stools, severe diarrhea and frequent abdominal pain. Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus. Because the inflammation makes the colon empty frequently, symptoms typically include diarrhea (sometimes bloody) and severe abdominal pain, often leading to weight loss, anemia and a host of secondary complications. When conventional treatments do not control the symptoms of the disease, it is estimated that as many as 30 percent of UC patients will undergo a colectomy, which is a surgical removal of the colon.
About REMICADE
REMICADE is a monoclonal antibody that specifically targets tumor necrosis factor (TNF)-alpha, which has been shown to play a role in Crohn’s disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS) psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn’s disease (PCD) and psoriasis (PsO). REMICADE is the global market leader among anti-TNF-alpha therapies and was the first agent approved for the treatment of both RA and CD in North America, the EU and Japan. Additionally, REMICADE was the first anti-TNF approved in Europe in three different therapeutic areas: gastroenterology, rheumatology and dermatology. The safety and efficacy of REMICADE have been well established in clinical trials over the past 17 years.
In the EU, REMICADE is approved for the treatment of:
Severe, active CD in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Fistulizing, active CD in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
RA (in combination with methotrexate) for the reduction of signs and symptoms, as well as the improvement in physical function in adult patients with active RA when the response to disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate; and in patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of progression of joint damage, as measured by X-ray, has been demonstrated.
Severe, active AS in adult patients who have responded inadequately to conventional therapy.
Active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate. REMICADE should be administered in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. REMICADE has been shown to improve physical function in patients with PsA, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Moderate-to-severe plaque PsO in adults who failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate or PUVA (psoralen plus ultraviolet A light).
Moderately-to-severely active UC in adult patients who have had an inadequate response to conventional therapies, i.e. corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Severe, active CD in pediatric patients aged 6 to 17 years who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies. REMICADE has been studied only in combination with conventional immunosuppressive therapy.
REMICADE is the only anti-TNF biologic therapy available as an intravenous (IV) administration. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is administered directly by caregivers in the clinic or office setting. REMICADE patients may require as few as six treatments each year.
Important Safety Information
There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia, in patients taking REMICADE. Some of these infections have been fatal. Patients should tell their doctors if they have had recent or past exposure to people with TB. Their doctors will evaluate them for TB and may perform tests for TB. If patients have latent (inactive) TB, their doctors should begin TB treatment before they start REMICADE. REMICADE can lower patients’ ability to fight infections, so if they are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE, patients should tell their doctors right away. Also, patients should tell their doctors if they are scheduled to receive a vaccine or if they have lived in a region where histoplasmosis, blastomycosis or coccidioidomycosis are common.
Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare, but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Rarely, children and young adults who have been treated for Crohn’s disease or ulcerative colitis with REMICADE in combination with azathioprine or 6-mercaptopurine have developed a rare type of lymphoma, hepatosplenic T cell lymphoma (HSTL) that often results in death. Patients taking REMICADE or other TNF blockers may be at an increased risk for developing lymphoma or other cancers. Patients should also tell their doctors if they have had or develop lymphoma or other cancers or if they have a lung disease called chronic obstructive pulmonary disease (COPD).
Many people with heart failure should not take REMICADE; so prior to treatment they should discuss any heart condition with their doctors. Patients should tell their doctors right away if they develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of your ankles or feet, or sudden weight gain).
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. All patients should be screened for signs of an infection and a hepatitis B expert should be consulted if a patient tests positive for hepatitis B surface antigen.
There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Patients should tell their doctors if they have liver problems and contact their doctors immediately if they develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.
Blood disorders in people taking REMICADE have been reported, some fatal. Patients should tell their doctors if they develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Patients should tell their doctors if they have or have had a disease that affects the nervous system, or if they experience any numbness, weakness, tingling, visual disturbances or seizures while taking REMICADE.
Allergic reactions, some severe have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. REMICADE should not be administered to patients with known hypersensitivity to REMICADE or any component of REMICADE. Patients should tell their doctors if they have experienced a severe allergic reaction. The most common side effects of REMICADE are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing, and stomach pain.
Complete EU prescribing information can be found at www.emea.europa.eu.
About MSD
Today’s MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.msd.com and connect with us on Twitter, Facebook and YouTube.
SOURCE: MSD
Post Views: 46
Positive Opinion Recommends Approval of the First and Only Anti-TNF Therapy in Pediatric Patients with Severely Active Ulcerative Colitis, a Chronic, Inflammatory Bowel Disease
WHITEHOUSE STATION, NJ, USA I January 20, 2012 I MSD (also known as Merck in the United States and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the use of REMICADE® (infliximab) in the treatment of severely active ulcerative colitis (UC) in pediatric patients ages 6 to 17 years, who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. REMICADE, a monoclonal antibody that specifically targets tumor necrosis factor (TNF)-alpha, was approved in the European Union (EU) in March 2006 for the treatment of moderately to severely active UC in adults. REMICADE has been used in the treatment of inflammatory bowel disease (IBD) for more than 12 years in the EU, having been first approved for severely active Crohn’s disease in adults in 1999, and more recently, moderately to severely active pediatric Crohn’s disease in 2007.
Upon receipt of the corresponding Commission Decision, REMICADE will be the first and only biologic therapy approved in the EU for the treatment of pediatric UC, a debilitating condition that causes inflammation and painful swelling of the inner lining of the large intestine.
“For parents of children who suffer from the sometimes devastating effects of ulcerative colitis, the positive opinion adopted by the CHMP is encouraging news and a significant step towards making REMICADE available to a younger patient population in Europe,” said Rupert Vessey, MRCP, DPhil, Senior Vice President, Research Laboratories, Merck. “Building on our long heritage in immunology, today’s positive opinion further reinforces the efficacy of REMICADE in the treatment of inflammatory bowel disease and our commitment to expanding treatment options for patients in Europe.”
The CHMP adopted their opinion based on a review of data from a Phase 3 multicenter, randomized, open-label, parallel-group clinical study that assessed the efficacy and safety of REMICADE in 60 pediatric patients ages 6 through 17 years diagnosed with moderately to severely active ulcerative colitis who had experienced an inadequate response to conventional therapies. Findings from the 54-week study showed the efficacy of REMICADE in this pediatric population.
A final decision from the European Commission is expected during the first quarter of 2012.
Janssen Biotech, Inc. discovered and developed REMICADE and markets the product in the United States. The Janssen Pharmaceutical Companies market REMICADE in Canada, Central and South America, the Middle East, Africa and Asia Pacific.
In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to REMICADE to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc.
About Pediatric Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowl disease that causes inflammation, or painful swelling, of the colon mucosa, or innermost lining of the large intestine. Symptoms typically include bloody stools, severe diarrhea and frequent abdominal pain, which often impacts school and social activities. Children with pediatric ulcerative colitis may also experience delayed growth. Although ulcerative colitis may occur at any pediatric age, it is most often diagnosed in early adolescence and affects males and females equally. While long periods of remission are possible, children with ulcerative colitis typically must mange the disease the rest of their lives.
About Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease affecting more than 700,000 people in the European Union. It is marked by the inflammation and ulceration of the colon mucosa, or innermost lining, which causes bloody stools, severe diarrhea and frequent abdominal pain. Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus. Because the inflammation makes the colon empty frequently, symptoms typically include diarrhea (sometimes bloody) and severe abdominal pain, often leading to weight loss, anemia and a host of secondary complications. When conventional treatments do not control the symptoms of the disease, it is estimated that as many as 30 percent of UC patients will undergo a colectomy, which is a surgical removal of the colon.
About REMICADE
REMICADE is a monoclonal antibody that specifically targets tumor necrosis factor (TNF)-alpha, which has been shown to play a role in Crohn’s disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS) psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn’s disease (PCD) and psoriasis (PsO). REMICADE is the global market leader among anti-TNF-alpha therapies and was the first agent approved for the treatment of both RA and CD in North America, the EU and Japan. Additionally, REMICADE was the first anti-TNF approved in Europe in three different therapeutic areas: gastroenterology, rheumatology and dermatology. The safety and efficacy of REMICADE have been well established in clinical trials over the past 17 years.
In the EU, REMICADE is approved for the treatment of:
Severe, active CD in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Fistulizing, active CD in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
RA (in combination with methotrexate) for the reduction of signs and symptoms, as well as the improvement in physical function in adult patients with active RA when the response to disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate; and in patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of progression of joint damage, as measured by X-ray, has been demonstrated.
Severe, active AS in adult patients who have responded inadequately to conventional therapy.
Active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate. REMICADE should be administered in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. REMICADE has been shown to improve physical function in patients with PsA, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Moderate-to-severe plaque PsO in adults who failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate or PUVA (psoralen plus ultraviolet A light).
Moderately-to-severely active UC in adult patients who have had an inadequate response to conventional therapies, i.e. corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Severe, active CD in pediatric patients aged 6 to 17 years who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies. REMICADE has been studied only in combination with conventional immunosuppressive therapy.
REMICADE is the only anti-TNF biologic therapy available as an intravenous (IV) administration. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is administered directly by caregivers in the clinic or office setting. REMICADE patients may require as few as six treatments each year.
Important Safety Information
There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia, in patients taking REMICADE. Some of these infections have been fatal. Patients should tell their doctors if they have had recent or past exposure to people with TB. Their doctors will evaluate them for TB and may perform tests for TB. If patients have latent (inactive) TB, their doctors should begin TB treatment before they start REMICADE. REMICADE can lower patients’ ability to fight infections, so if they are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE, patients should tell their doctors right away. Also, patients should tell their doctors if they are scheduled to receive a vaccine or if they have lived in a region where histoplasmosis, blastomycosis or coccidioidomycosis are common.
Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare, but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Rarely, children and young adults who have been treated for Crohn’s disease or ulcerative colitis with REMICADE in combination with azathioprine or 6-mercaptopurine have developed a rare type of lymphoma, hepatosplenic T cell lymphoma (HSTL) that often results in death. Patients taking REMICADE or other TNF blockers may be at an increased risk for developing lymphoma or other cancers. Patients should also tell their doctors if they have had or develop lymphoma or other cancers or if they have a lung disease called chronic obstructive pulmonary disease (COPD).
Many people with heart failure should not take REMICADE; so prior to treatment they should discuss any heart condition with their doctors. Patients should tell their doctors right away if they develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of your ankles or feet, or sudden weight gain).
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. All patients should be screened for signs of an infection and a hepatitis B expert should be consulted if a patient tests positive for hepatitis B surface antigen.
There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Patients should tell their doctors if they have liver problems and contact their doctors immediately if they develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.
Blood disorders in people taking REMICADE have been reported, some fatal. Patients should tell their doctors if they develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Patients should tell their doctors if they have or have had a disease that affects the nervous system, or if they experience any numbness, weakness, tingling, visual disturbances or seizures while taking REMICADE.
Allergic reactions, some severe have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. REMICADE should not be administered to patients with known hypersensitivity to REMICADE or any component of REMICADE. Patients should tell their doctors if they have experienced a severe allergic reaction. The most common side effects of REMICADE are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing, and stomach pain.
Complete EU prescribing information can be found at www.emea.europa.eu.
About MSD
Today’s MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.msd.com and connect with us on Twitter, Facebook and YouTube.
SOURCE: MSD
Post Views: 46
