Gilead Sciences, Inc
) suffered two successive setbacks when the US Food and Drug
Administration (FDA) issued complete response letters (CRLs) to
the company's HIV candidates, elvitegravir and cobicistat, for
use as part of HIV therapy regimens.
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We note that Gilead is seeking approval of elvitegravir for use
in treatment-experienced HIV patients. Cobicistat acts as a
"boosting" agent whose addition causes blood levels of protease
inhibitors to increase, thereby enabling the HIV therapy to be
dosed once daily.
The US regulatory body declined to approve the candidates on the
basis of the submitted data due to shortcomings observed in the
documentation and validation of certain quality testing methods.
Gilead is working with the US regulatory body to address the
queries raised in the CRLs.
We note that Gilead had submitted the new drug applications
(NDAs) seeking FDA approvals for the candidates in Jun 2012. Both
applications were subsequently accepted for review by the FDA.
The FDA had assigned target dates of Apr 27 and Apr 28, 2013 for
deciding on the NDAs of elvitegravir and cobicistat,
Even though the US regulatory body declined to approve the HIV
candidates in their present forms, the agency did not ask for
additional studies to be conducted. This brings in some relief
for Gilead as additional studies would have pushed up the
research & development costs for the company and delayed the
approval even further.
We note that elvitegravir and cobicistat are also components of
Gilead's HIV combination pill Stribild, approved in the US in Aug
2012 as a first-line therapy for treating adults infected with
the HIV virus. The other component of the pill is Truvada.
The CRLs issued by the FDA regarding elvitegravir and cobicistat
individually will not impact Stribild in any way.
Gilead carries a Zacks Rank #3 (Hold). Companies that look
Cleveland BioLabs, Inc
). All three are Zacks Rank #1 (Strong Buy) stocks.