Merck Receives Expanded License For Isentress

Merck Sharp & Dohme (MSD) has reported that Isentress (raltegravir) has been granted an expanded license from the European Union Commission for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients.

The safety and efficacy of Isentress has not been established in patients below 16 years of age. The Commission’s decision is applicable to the 27 Member States of the EU, including France, Germany, Italy, Spain and the UK as well as to Iceland and Norway.

The company said that the Commission’s decision, reflecting the positive opinion of the Committee for Medicinal Products for Human Use (CHMP), was based on data from three double-blind controlled phase III studies.

Two of these studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naive adults. In the study with treatment-naive patients (STARTMRK), raltegravir was found to be as effective as efavirenz at suppressing viral load and restoring immune system function through 48 weeks in treatment-naive patients. Both medicines were administered in combination with tenofovir and emtricitabine.

Patrick Bergstedt, senior vice president and general manager of Infectious Diseases at Merck, said: “We are pleased that raltegravir will now be available to a broader spectrum of adult HIV patients. The expanded license is important because it gives adult patients starting HIV therapy for the first time an additional treatment option.”