KENILWORTH, NJ, USA I May 19, 2017 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ISENTRESS® (raltegravir) 600 mg film-coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. In adults and pediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second half of 2017.
The once daily formulation of ISENTRESS is currently under review in the United States by the Food and Drug Administration.
“The CHMP’s positive opinion recommending the approval of ISENTRESS 600 mg film-coated tablets is an important step toward a new option for people living with HIV who are looking for once-daily dosing, as part of an HIV treatment regimen, with proven efficacy and safety,” said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories.
The CHMP positive opinion was based on findings from the ONCEMRK trial, an ongoing Phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial designed to evaluate the efficacy and safety of ISENTRESS 1200 mg, given as two 600 mg oral tablets once daily, compared to ISENTRESS 400 mg twice daily, each in combination with emtricitabine + tenofovir disoproxil fumarate in previously untreated HIV-1 infected adults. Once-daily ISENTRESS 600 mg (1200 mg total), when used as part of an HIV-1 treatment regimen, demonstrated comparable efficacy and safety to ISENTRESS 400 mg twice a day after 48-weeks of treatment across a variety of patient populations.
About ISENTRESS (raltegravir)
ISENTRESS is Merck’s integrase inhibitor for the treatment of HIV-1 infection in adult and pediatric patients aged four weeks and older and weighing at least 3 kg as part of combination HIV therapy. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.
ISENTRESS is approved as part of combination therapy in 112 countries for treatment of HIV-1 infection in adults. ISENTRESS chewable tablets, in combination therapy, for use in children and adolescents with HIV-1 aged two years and older has also been approved for use in 69 countries, and ISENTRESS granules for oral suspension for infants at least four weeks of age is approved for use in 33 countries.
About Merck
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies 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 health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 134
KENILWORTH, NJ, USA I May 19, 2017 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ISENTRESS® (raltegravir) 600 mg film-coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. In adults and pediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second half of 2017.
The once daily formulation of ISENTRESS is currently under review in the United States by the Food and Drug Administration.
“The CHMP’s positive opinion recommending the approval of ISENTRESS 600 mg film-coated tablets is an important step toward a new option for people living with HIV who are looking for once-daily dosing, as part of an HIV treatment regimen, with proven efficacy and safety,” said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories.
The CHMP positive opinion was based on findings from the ONCEMRK trial, an ongoing Phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial designed to evaluate the efficacy and safety of ISENTRESS 1200 mg, given as two 600 mg oral tablets once daily, compared to ISENTRESS 400 mg twice daily, each in combination with emtricitabine + tenofovir disoproxil fumarate in previously untreated HIV-1 infected adults. Once-daily ISENTRESS 600 mg (1200 mg total), when used as part of an HIV-1 treatment regimen, demonstrated comparable efficacy and safety to ISENTRESS 400 mg twice a day after 48-weeks of treatment across a variety of patient populations.
About ISENTRESS (raltegravir)
ISENTRESS is Merck’s integrase inhibitor for the treatment of HIV-1 infection in adult and pediatric patients aged four weeks and older and weighing at least 3 kg as part of combination HIV therapy. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.
ISENTRESS is approved as part of combination therapy in 112 countries for treatment of HIV-1 infection in adults. ISENTRESS chewable tablets, in combination therapy, for use in children and adolescents with HIV-1 aged two years and older has also been approved for use in 69 countries, and ISENTRESS granules for oral suspension for infants at least four weeks of age is approved for use in 33 countries.
About Merck
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies 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 health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 134
