Merck has received approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for ISENTRESS, a 600 mg. tablet coated in film and paired with other anti-retroviral prescriptions for those who have been diagnosed HIV-1.
It is recommended that patients who weigh at least 88 pounds take two of the tablets once a day.
The next step is for the European Commission for marketing authorization to evaluate the drug in the European Union. The organization is expected to make a decision this year.
“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,” Dr. Eliav Barr, Merck's senior vice president of global clinical development, infectious diseases and vaccines, said.
The CHMP based its opinion on a 3-phase trial period under ONCEMRK. ISENTRESS was said to “demonstrate comparable efficacy” when used to treat HIV patients.
The U.S. Food and Drug Administration is analyzing the drug.