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GlaxoSmithKline's Long-Acting HIV Regimen Gets CRL From FDA

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GlaxoSmithKline plc’s (GSK - Free Report)  HIV subsidiary, ViiV Healthcare, and partner J&J JNJ received a complete response letter (CRL) from the FDA for its investigational long-acting injectable regimen of cabotegravir and J&J’s Edurant (rilpivirine) for the treatment of HIV-1 infection in virologically suppressed adults.

Glaxo said the CRL was related to to chemistry, manufacturing and controls (CMC) and there were no reported safety issues related to CMC.

ViiV Healthcare had filed the NDA for the long-acting regimen in April which was granted priority review by the FDA in July.

ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer PFE

So far this year, Glaxo’s shares have rallied 23.8% compared with the industry’s 11.9% growth.

HIV is a key therapeutic area for Glaxo, with successful dolutegravir-based regimens — Tivicay, Triumeq and Juluca — in its portfolio. In April, ViiV Healthcare obtained FDA approval for a single-tablet, two-drug regimen Dovato for the treatment of naïve HIV-1 adults. 

ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms (two-drug regimens), modalities (long-acting injectables) and mechanisms of actions (including maturation inhibitors and broadly neutralizing antibodies). Other than the long-acting, injectable, two-drug regimen of cabotegravir and rilpivirine, Glaxo has fostemsavir in its HIV pipeline, developed to treat heavily pretreated HIV patients. An NDA for fostemsavir was filed in December.

Other key players in the HIV market are Gilead GILD, Merck, AbbVie and J&J.

Glaxo currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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