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Glaxo's Long-Acting HIV Regimen Gets FDA's Priority Status

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GlaxoSmithKline plc’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare, received Priority Review designation from the FDA for the new drug application for its long-acting, injectable two-drug HIV regimen

Glaxo had filed the NDA in April seeking approval for the two-drug monthly regimen of its candidate cabotegravir and J&J’s (JNJ - Free Report) Edurant (rilpivirine) for the treatment of HIV-1-infected adults who had maintained viral suppression and who are not resistant to cabotegravir or rilpivirine.With the FDA granting a Priority Review in June, a decision is expected on Dec 29, 2019. 

Meanwhile, ViiV Healthcare also announced the start of the first-ever study — CUSTOMIZE — to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in the real world. This approach can be different and an improvement from the controlled setting of a clinical study

ViiV Healthcare is an HIV company majorly owned by Glaxo and Pfizer (PFE - Free Report) .

So far this year, Glaxo’s shares have outperformed the industry, rising 6% compared with the industry’s 2.6% increase.



HIV is a key therapeutic area for Glaxo with successful dolutegravir-based regimens, Tivicay, Triumeqand Juluca in its portfolio. In April, ViiV Healthcare gained FDA approval for a single-tablet two-drug regimen, Dovato for treatment naïve HIV- 1 adults. HIV sales totaled £1.12 billion in the first quarter of 2019 with dolutegravir-based regimens generating £1.07 million, which partly offset lower sales of established HIV products. However, on the call, the company specified that growth in the dolutegravir franchise was slower than past quarters due to a more competitive environment.

ViiV Healthcare is focused on advancing HIV care by exploring new treatment paradigms (two-drug regimens), new modalities (long-acting injectables) and new 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, which has been developed to treat heavily pre-treated HIV patients. An NDA for fostemsavir is expectedto be filedin second-half 2019.

Other key players in the HIV market are Gilead (GILD - Free Report) , Merck, AbbVie and J&J.

Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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