Merck Sharp & Dohme Limited (MSD) announced today that ISENTRESS® (raltegravir) has been granted an expanded licence from the European Union Commission (Commission) for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as treatment-experienced 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 European Union (EU), including France, Germany, Italy, Spain and the United Kingdom as well as to Iceland and Norway.
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-naïve adults. In the study with treatment-naïve patients (STARTMRK), raltegravir was found to be as effective as efavirenz (one of the standard antiretrovirals prescribed for treatment-naïve patients) at suppressing viral load and restoring immune system function through 48 weeks in treatment-naïve patients. Both medicines were administered in combination with tenofovir and emtricitabine.
"Having a therapeutic option like raltegravir, with an efficacy and safety profile established through clinical studies, provides adult patients treated for the first time with a new way of targeting the virus," said Dr. Adriano Lazzarin, professor of Infectious Illnesses, University Vita-Salute San Raffaele, Milan, Italy. "New treatment options in the EU may help physicians to better individualise treatment regimens, which is important due to the complexity of HIV and increasingly diverse patient needs."
Despite the availability of drugs to treat HIV and AIDS, the pandemic continues. In the EU, nearly 270,000 cases of HIV have been reported since 2002, according to the European Centre for the Epidemiological Monitoring of HIV and AIDS. Worldwide, an estimated 33 million people are infected with HIV and AIDS, and about 2.7 million new infections occurred worldwide in 2007.
“Merck Sharp & Dohme is committed to bringing innovative therapies to patients who need them most, and we are pleased that raltegravir will now be available to a broader spectrum of adult HIV patients. The expanded licence is important because it gives adult patients starting HIV therapy for the first time an additional treatment option,” said Patrick Bergstedt, senior vice president and general manager of Infectious Diseases at Merck and Co., Inc.