Bristol-Myers Squibb has secured EU approval for its new HIV therapy Evotaz, a few months after getting the green light for the drug in the US.
Evotaz combines BMS’ HIV-1 protease inhibitor Reyataz (atazanavir) with Tybost (cobicistat), a boosting agent developed by Gilead Sciences that is already approved for use in a number of other drug formulations.
The once-daily pill has been approved for use in combination with other antiretroviral drugs and was given a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in May.
Reyataz has been a big seller for BMS with sales peaking at around $1.5bn, although it has been impacted by the emergence of single-tablet HIV combinations such as Gilead’s Atripla and Stribild, Johnson & Johnson’s Complera and ViiV Healthcare’s Triumeq. Sales of the drug dipped 12% to $1.36bn last year.
“HIV remains a significant public health concern throughout the world, and the increase in new infections in recent years in Europe means that it is more important than ever to continue to deliver new treatment options to help patients achieve virologic suppression,” said Murdo Gordon, head of worldwide markets at BMS.
“By combining reduced pill burden with a low rate of virologic failure and no protease inhibitor mutations, Evotaz increases the possibility of suppressing HIV, and we are pleased to bring it to physicians and patients in the EU.”
Manufacturers of all HIV therapies are anticipating a boost from the recent guidance from the National Institute of Allergy and Infectious Diseases (NIAID) in the US that recommends patients with HIV start taking antiretroviral medications as soon as they are diagnosed rather than waiting for the CD$ cell counts to dip below 500.
However, BMS recently announced that it was halting early-stage discovery research in virology – including hepatitis B and HIV – with the loss of around 100 research positions, but stressed the decision would not affect marketed and clinical-stage drug candidates.
The decision reflects research suggesting that the overall market for HIV drugs has started to plateau and will likely start to decline as a second-generation of blockbuster medicines – with good efficacy and simpler dosing schedules compared to first-generation generic antiretrovirals – start to lose patent protection.