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.
BioSpace Temperature Poll
Can Sanofi Snag a New CEO?
French biopharma giant
Sanofi
has had a difficult time finding a replacement willing to take the CEO job after ousting popular chief
Chris Viehbacher
last fall. So far, at least three marquee-name candidates have turned down the job, including execs from
Takeda
and
AstraZeneca
. Do you think
Sanofi
will be able to fill this position any time soon? BioSpace wants your opinion!
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