Data Will Be Submitted to the FDA for ACTEMRA Subcutaneous Formulation
SOUTH SAN FRANCISCO, CA, USA I July 27, 2012 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the BREVACTA study of ACTEMRA (tocilizumab) given as a subcutaneous (SC) injection to patients with rheumatoid arthritis (RA) met its primary endpoint. After 24 weeks of treatment, RA patients who received ACTEMRA every two weeks were significantly more likely to have experienced at least a 20 percent improvement in tender and swollen joints than those given placebo injections (ACR20). A preliminary safety analysis showed that the adverse event profile of ACTEMRA SC was consistent with previous findings.
BREVACTA is the second positive study of a SC formulation of ACTEMRA and follows results reported in May from the SUMMACTA study. Genentech intends to submit these data to the U.S. Food and Drug Administration (FDA) to gain approval for the SC formulation of ACTEMRA.
“These two studies mark a significant milestone for ACTEMRA, consistently demonstrating that a subcutaneous formulation provides clinically meaningful results for patients with rheumatoid arthritis,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “If approved, doctors and patients will have an important alternative treatment option to choose from.”
RA is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged. Preventing or slowing the progression of damage to RA patients’ joints is an important aim of treatment, preserving functionality and mobility.
Analysis of x-ray results, a secondary endpoint in BREVACTA, also showed patients who received ACTEMRA SC every two weeks were significantly less likely to have experienced worsening joint damage at Week 24 than those given a placebo SC injection in combination with disease-modifying antirheumatic drugs (DMARDs). Statistical significance was also achieved on other key secondary endpoints including ACR50 and 70, DAS28 low disease activity and DAS28 remission.
Data from BREVACTA will be submitted for presentation at an upcoming medical meeting.
About BREVACTA
BREVACTA is a randomized, double-blind, parallel-group study of ACTEMRA SC versus placebo SC in combination with traditional DMARDs in patients with moderately to severely active RA who had an inadequate response to DMARD therapy. BREVACTA was designed to assess the efficacy of treatment with ACTEMRA 162 mg SC given every two weeks versus placebo given every two weeks, both in combination with DMARDs, based on ACR20 response at Week 24. The safety profile was assessed with regard to adverse events and laboratory assessments.
In the study, 656 patients were randomly assigned in a 2:1 ratio to two treatment groups at baseline. 437 patients received ACTEMRA SC (Group A) every two weeks administered with a prefilled syringe (PFS) and 219 patients received placebo SC (Group B) every two weeks with a PFS. All patients continued their background DMARD therapy. At Week 24, patients were re-randomized to continue receiving administration with the PFS or to change to administration with an autoinjector (AI). Furthermore, all patients on placebo were switched to receive ACTEMRA SC 162 mg every two weeks. Secondary endpoints included assessment of prevention of progression of structural joint damage at Week 24 between the two groups, ACR50 and 70, DAS28 low disease activity and DAS28 remission.
About ACR 20, 50, 70
American College of Rheumatology (ACR) scores represent the percentage of reduction (20 percent, 50 percent, 70 percent) in tender and swollen joint counts, in addition to a corresponding improvement in three of the following five parameters:
Acute phase reactant (such as erythrocyte sedimentation rate)
Patients Global Assessment of Disease Activity
Physicians Global Assessment of Disease Activity
Pain scale
Health Assessment Questionnaire (HAQ)
About DAS28
DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (a marker of systemic inflammation), and the patient’s ‘global assessment of global health’ (indicated by marking a 10 cm line between ‘very good’ and ‘very bad’). A DAS28 score greater than 5.1 indicates severe active disease, less than 3.2 low disease activity, and less than 2.6 is termed DAS remission.
About ACTEMRA® (tocilizumab)
ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, ACTEMRA is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
Important Safety Information
Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection becoming an active infection again, and nervous system problems.
Serious allergic reactions, including death, can happen with ACTEMRA. These reactions may happen with any infusion of ACTEMRA even if they did not occur with an earlier infusion. Patients must tell their doctor if they have had a previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are allergic to it or any of its ingredients.
Common side effects with ACTEMRA in RA include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).
Common side effects with ACTEMRA in SJIA include upper respiratory tract infections (common cold, sinus infections), headache, and diarrhea.
Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.
Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555.
For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit http://www.actemra.com or call 1-800-ACTEMRA (228-3672).
ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. ACTEMRA is approved in the European Union, where it is known as RoACTEMRA, and several other countries, including India, Brazil, Switzerland and Australia.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 90
Data Will Be Submitted to the FDA for ACTEMRA Subcutaneous Formulation
SOUTH SAN FRANCISCO, CA, USA I July 27, 2012 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the BREVACTA study of ACTEMRA (tocilizumab) given as a subcutaneous (SC) injection to patients with rheumatoid arthritis (RA) met its primary endpoint. After 24 weeks of treatment, RA patients who received ACTEMRA every two weeks were significantly more likely to have experienced at least a 20 percent improvement in tender and swollen joints than those given placebo injections (ACR20). A preliminary safety analysis showed that the adverse event profile of ACTEMRA SC was consistent with previous findings.
BREVACTA is the second positive study of a SC formulation of ACTEMRA and follows results reported in May from the SUMMACTA study. Genentech intends to submit these data to the U.S. Food and Drug Administration (FDA) to gain approval for the SC formulation of ACTEMRA.
“These two studies mark a significant milestone for ACTEMRA, consistently demonstrating that a subcutaneous formulation provides clinically meaningful results for patients with rheumatoid arthritis,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “If approved, doctors and patients will have an important alternative treatment option to choose from.”
RA is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged. Preventing or slowing the progression of damage to RA patients’ joints is an important aim of treatment, preserving functionality and mobility.
Analysis of x-ray results, a secondary endpoint in BREVACTA, also showed patients who received ACTEMRA SC every two weeks were significantly less likely to have experienced worsening joint damage at Week 24 than those given a placebo SC injection in combination with disease-modifying antirheumatic drugs (DMARDs). Statistical significance was also achieved on other key secondary endpoints including ACR50 and 70, DAS28 low disease activity and DAS28 remission.
Data from BREVACTA will be submitted for presentation at an upcoming medical meeting.
About BREVACTA
BREVACTA is a randomized, double-blind, parallel-group study of ACTEMRA SC versus placebo SC in combination with traditional DMARDs in patients with moderately to severely active RA who had an inadequate response to DMARD therapy. BREVACTA was designed to assess the efficacy of treatment with ACTEMRA 162 mg SC given every two weeks versus placebo given every two weeks, both in combination with DMARDs, based on ACR20 response at Week 24. The safety profile was assessed with regard to adverse events and laboratory assessments.
In the study, 656 patients were randomly assigned in a 2:1 ratio to two treatment groups at baseline. 437 patients received ACTEMRA SC (Group A) every two weeks administered with a prefilled syringe (PFS) and 219 patients received placebo SC (Group B) every two weeks with a PFS. All patients continued their background DMARD therapy. At Week 24, patients were re-randomized to continue receiving administration with the PFS or to change to administration with an autoinjector (AI). Furthermore, all patients on placebo were switched to receive ACTEMRA SC 162 mg every two weeks. Secondary endpoints included assessment of prevention of progression of structural joint damage at Week 24 between the two groups, ACR50 and 70, DAS28 low disease activity and DAS28 remission.
About ACR 20, 50, 70
American College of Rheumatology (ACR) scores represent the percentage of reduction (20 percent, 50 percent, 70 percent) in tender and swollen joint counts, in addition to a corresponding improvement in three of the following five parameters:
Acute phase reactant (such as erythrocyte sedimentation rate)
Patients Global Assessment of Disease Activity
Physicians Global Assessment of Disease Activity
Pain scale
Health Assessment Questionnaire (HAQ)
About DAS28
DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (a marker of systemic inflammation), and the patient’s ‘global assessment of global health’ (indicated by marking a 10 cm line between ‘very good’ and ‘very bad’). A DAS28 score greater than 5.1 indicates severe active disease, less than 3.2 low disease activity, and less than 2.6 is termed DAS remission.
About ACTEMRA® (tocilizumab)
ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, ACTEMRA is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
Important Safety Information
Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection becoming an active infection again, and nervous system problems.
Serious allergic reactions, including death, can happen with ACTEMRA. These reactions may happen with any infusion of ACTEMRA even if they did not occur with an earlier infusion. Patients must tell their doctor if they have had a previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are allergic to it or any of its ingredients.
Common side effects with ACTEMRA in RA include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).
Common side effects with ACTEMRA in SJIA include upper respiratory tract infections (common cold, sinus infections), headache, and diarrhea.
Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.
Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555.
For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit http://www.actemra.com or call 1-800-ACTEMRA (228-3672).
ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. ACTEMRA is approved in the European Union, where it is known as RoACTEMRA, and several other countries, including India, Brazil, Switzerland and Australia.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 90
