Boston, MA 04/17/2014 (wallstreetpr) – Bristol-Myers Squibb Co (NYSE:BMY) said that it has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval of a combination that combines its HIV treatment vaccine called Reyataz whose chemical name is Atazanavir Sulfate and Gilead Sciences, Inc. (NASDAQ:GILD) Cobicistat for treating the HIV virus. Reyataz is the first known protease inhibitor approved for once a day administration because it causes less lipodystrophy and also does not adversely affect cholesterol levels. Cobicistat enhances the efficacy of certain HIV-1 therapies by elevating their levels in the blood. Cobicistat can do so by preventing liver enzymes that metabolize other medications used to treat HIV.
Bristol-Myers Squibb Co (NYSE:BMY) is looking to get Reyataz approved in conjunction with other known antiretroviral agents for the treatment of AIDS infection. If the request is approved then the combination treatment will make matters a lot easier for HIV-1 patients, as it eliminates the need to take a boosting agent tablet.
The new line of treatment would revolutionize antiretroviral drug administration, which for quite some time premised on the assumption that to be effective for a long time one needed to take more than one antiretroviral drug at a time. The method of treatment is known as combination therapy or technically Highly Active Antiretroviral Therapy (HAART).
Bristol-Myers emphasized in its press release that Reyataz is the only known protease inhibitor to be studied in combination with Cobicistat. The study conducted by Gilead Sciences’ compared the effectiveness and safety of Cobicistat-boosted Reyataz with a similar combination between Reyataz and AbbVie Inc. (NYSE:ABBV) HIV therapy Norvir (ritonavir) over a 48 weeks in treatment trial involving HIV infected adults. The company further stated that it would provide further updates on the fixed-dose combination therapy keeping in mind investor interest and also interest of public at large.
It may be interesting to note that Bristol-Myers Squibb Co (NYSE:BMY) and Gilead Sciences, Inc. (NASDAQ:GILD) had teamed up in 2011 for developing and commercializing the combination for the first time.
