FDA Green Lights Bristol-Myers Squibb Company, Johnson & Johnson HIV Pills

Published: Jan 30, 2015

FDA Green Lights Bristol-Myers Squibb Company, Johnson & Johnson HIV Pills
January 30, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration (FDA) approved two similar HIV drugs on Thursday, one made by Bristol-Myers Squibb Company and the other by Johnson & Johnson . Both drugs are fixed-dose pills that combine protease inhibitors and a boosting agent produced by Gilead Sciences, Inc. .

Bristol-Myers’ drug Evotaz combines the protease inhibitor Reyataz, also known as atazanavir, and cobicistat, a pharmacokinetic enhancer made by Gilead. J&J’s drug Prezcobix combines the protease inhibitor Prezista, also known as darunavir, with cobicistat.

“We are pleased to provide physicians and patients with an important new option to treat HIV; atazanavir with cobicistat delivers sustained efficacy and safety through 48 weeks, as demonstrated through its rigorous clinical development plan, including a head-to-head Phase III trial,” said Murdo Gordon, head of worldwide markets at Bristol-Myers, in a statement. “Evotaz increases the possibility of providing HIV suppression by combining reduced pill burden with a low rate of virologic failure and zero protease inhibitor mutations.”

The big news for patients with HIV is that this approval makes available an effective treatment with one fewer pill. Research confirmed that Evotaz is bioequivalent to the co-administration of its components, Reyataz and cobicistat, when given with a light meal, according to Bristol-Meyers.

“Pharmacokinetic studies and a large clinical trial have demonstrated that we can expect the same atazanavir drug levels and clinical efficacy from Evotaz as with ritonavir-boosted Reyataz with one less pill,” said study investigator Joel Gallant, associate medical director of Specialty Services at Southwest CARE Center in Santa Fe, New Mexico, and adjunct professor of medicine in the Division of Infectious Diseases at the Johns Hopkins University School of Medicine.

Gilead Sciences has signed separate licensing agreements regarding cobicistat with Bristol-Meyers and with a subsidiary of J&J, the Ireland-based Tibotec Pharmaceuticals, in 2011. In both cases, Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents. Bristol-Meyers and J&J are each responsible for the formulation, manufacturing, registration, distribution and commercialization of the drug that contains cobicistat.

When Gilead announced the licensing agreement with J&J, Norbert Bischofberger, Gilead's executive vice president of research and development and chief scientific officer, emphasized that such partnerships represent a commitment to improve the lives of those with HIV. “This agreement represents another important step forward in our commitment to developing simplified treatment regimens that can help address the individual needs of people living with HIV,” he said.


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