Label of Gilead's Complera Expanded - Analyst Blog
16 Décembre 2013 - 6:00PM
Zacks
Good news flowed in at
Gilead Sciences, Inc. (GILD) when the U.S. Food
and Drug Administration (FDA) approved its HIV single tablet
regimen Complera (once daily) for an additional indication. Gilead
gained FDA approval of Complera in certain virologically-suppressed
(HIV RNA <50 copies/mL) adults on a stable antiretroviral
regimen to replace their current antiretroviral therapy
regimen.
Approval was gained on the basis of encouraging data from a phase
III open-label, randomized study (SPIRIT: study 106). Complera, a
fixed-dose combination of Gilead’s Truvada (which in turn is a
fixed-dose drug of Gilead's Viread and Emtriva) and Johnson
and Johnson’s (JNJ) Edurant, was initially launched in the
U.S. in 2011 as a first-line therapy for HIV. Following the label
expansion, HIV infected adults can switch to Complera therapy from
other treatment regimens.
Complera is marketed as Eviplera in the EU since 2011 as a
first-line therapy in HIV infected adults. Currently, the regimen
is also approved in the EU for treating HIV infected adults without
known mutations associated with resistance to the non-nucleoside
reverse transcriptase inhibitor class, Gilead’s Viread or Emtriva.
Moreover, the viral load is less than or equal to 100,000 HIV-1 RNA
copies/mL.
Approval of Complera/ Eviplera for the new indication will further
boost the drug’s sales potential. The combination drug has
performed well since launch with sales in the third quarter of 2013
climbing 12% sequentially to $210.7 million.
Gilead, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). Some better-ranked stocks in the biopharma space include
Actelion Ltd. (ALIOF) and Vanda
Pharmaceuticals Inc. (VNDA). Both stocks carry a Zacks
Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
GILEAD SCIENCES (GILD): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
VANDA PHARMACT (VNDA): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
(USOTC:ALIOF)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
(USOTC:ALIOF)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024
Real-Time news about (OTCMarkets): 0 recent articles
Plus d'articles sur Actelion Ltd. (PC)