The European Commission has granted approval to Evotaz, a Bristol-Myers Squibb Company's combination pill used for the treatment of HIV-1 in adults.
The once-daily pill formulation is composed of a protease inhibitor, atazanavir (Reyataz), and a pharmacokinetic enhancer cobicistat (Tybost), according to Pharmabiz.com.
Evotaz is now allowed in the markets of 28 member nations of the European Union (EU). Yahoo Finance noted that this approval comes as no surprise because Evotaz had received positive feedback from the European Medicines Agency.
The drug is already approved for use in the U.S. since January this year and is given as an adjunct therapy to other anti-retroviral drugs intended for HIV-1 infection.
The EU approval was based on the data from the safety and efficacy trial of Evotaz versus a combination treatment of Reyataz and ritonavir.
The trial showed that Evotaz was successful at keeping virologic failure (when anti-retroviral therapy cannot completely suppress HIV) rates low.
At 48 weeks, the virologic failure was seen at six percent, and at 144 weeks at 8 percent.
According to Bristol-Myers Squibb head of specialty development Douglas Manion, the clinical efficacy of Evotaz as a once-daily formulation is important in reducing cases of drug resistance as well improve virologic suppression.
Based on the recent assessment from World Health Organization (WHO) and United Nations Programme on HIV and AIDS (UNAIDS), there are 2.2 million HIV-infected people in the European region. Between 2004 and 2013, over 300,000 new cases of infection were reported.
HIV is still a major public health concern all over the world and according to Murdo Gordon, head of Worldwide Markets, the rise in new cases over the past years means that it is more important to continue developing appropriate treatments to suppress HIV.
"By combining reduced pill burden with a low rate of virologic failure and no protease inhibitor mutations, Evotaz increases the possibility of suppressing HIV, and we are pleased to bring it to physicians and patients in the EU," Gordon said, according to Pharmabiz.
