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FDA Approves Evotaz

FDA Approves Evotaz (atazanavir and cobicistat) for HIV-1 Infection in Adults

PRINCETON, N.J. -- January 29, 2015 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences, Inc. Today’s approval offers patients living with HIV an innovative treatment option that delivers proven suppression (HIV-1 RNA <50 copies/mL, 85% Evotaz arm; 87% Reyataz/ritonavir arm) through 48 weeks.

The use of Evotaz in patients who have previously received HIV medication should be guided by their baseline resistance to protease inhibitors. Evotaz and Reyataz do not cure HIV-1 infection or AIDS. Evotaz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the product components and in combination with certain drugs.

“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, Bristol-Myers Squibb. “Evotaz increases the possibility of providing HIV suppression by combining reduced pill burden with a low rate of virologic failure (6% Evotaz arm; 4% Reyataz/ritonavir arm) and zero protease inhibitor mutations.” In the Evotaz arm, zero patients developed tenofovir-associated resistance K65R; two patients developed emtricitabine resistance M184V. In the Reyataz /ritonavir arm, zero resistance was observed.

Evotaz is the first and only protease inhibitor pharmacoenhanced by cobicistat that is supported by comparative Phase III trial data (Gilead Sciences, Inc.’s Study 114). The randomized, double-blind clinical trial (N=692) evaluated the efficacy and safety of Reyataz 300 mg with cobicistat 150 mg (the components of Evotaz) (n=344) versus Reyataz 300 mg with ritonavir 100 mg (Reyataz/ritonavir) (n=348), another pharmacokinetic enhancing agent, in combination with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults. Patients had a baseline estimated CrCL >70mL/min, a mean baseline plasma HIV-1 RNA of 4.8 log10 copies/mL, and a mean baseline CD4+ cell count of 352 cells/mm. At 48 weeks, 85% of patients in the Evotaz arm achieved HIV-1 RNA levels of <50 copies/mL compared to 87% of patients in the Reyataz/ritonavir arm. Low rates of virologic failure (HIV-1 RNA ≥50 copies/mL: 6% Evotaz arm; 4% Reyataz/ritonavir arm) were observed at 48 weeks, making Evotaz the only protease inhibitor pharmacoenhanced with cobicistat with virologic failure rates as low as 6%.

In the study, zero protease inhibitor resistance was detected through 48 weeks. No patients developed tenofovir‐associated resistance, and two patients in the Evotaz arm developed emtricitabine‐associated resistance. Various degrees of resistance and cross-resistance have been observed among protease inhibitors; however, resistance to atazanavir may not preclude the use of other protease inhibitors.

"Maintaining sufficient drug concentrations inhibits viral replication and prevents the development of resistance, which are critical considerations in treating patients with HIV,” 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. “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.”

Evotaz demonstrated a safety profile comparable to Reyataz/ritonavir. The most common moderate to severe adverse events in the Evotaz arm and Reyataz/ritonavir arm were: rash (5%, 4%); jaundice (5%, 3%); ocular iterus (3%, 1%); nausea (2%, 2%). There were similar low rates of discontinuation due to adverse events (AEs) with Evotaz as compared to Reyataz/ritonavir (7% and 7%, respectively).

Additional research confirmed that Evotaz is bioequivalent to the co-administration of its components, Reyataz and cobicistat, when given with a light meal.

In October 2011, Bristol-Myers Squibb announced a licensing agreement with Gilead for the development and commercialization of a once-daily, fixed-dose combination product of atazanavir and cobicistat, now named Evotaz. Under the terms of the agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the Evotaz fixed-dose combination product worldwide. 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.

About Bristol-Myers Squibb’s HIV Research Portfolio

For more than 20 years, Bristol-Myers Squibb has focused on discovering, developing and delivering innovative medicines to help meet the needs of patients living with HIV-1 and continues to pursue advances in treatment, for both children and adults with HIV-1. Studies are ongoing for new treatments including an HIV-1 attachment inhibitor (BMS-663068), an HIV-1 maturation inhibitor (BMS-955176) and an anti-PD-L1 (BMS-936559).

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Evotaz will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Source: Bristol-Myers Squibb

Posted: January 2015

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