GlaxoSmithKline plc’s GSK HIV subsidiary ViiV Healthcare announced that it has submitted a new drug application (NDA) to the FDA for its pipeline candidate fostemsavir for heavily treatment-experienced adult patients with HIV.
The candidate is being developed for use in combination with other antiretroviral agents in heavily pre-treated HIV patients, who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.
The NDA filing was based on data from the pivotal phase III BRIGHTE study. In July 2019, Glaxo presented week-96 data from the same study at the International AIDS Society Conference on HIV Science held in Mexico City.
The results showed that treatment with fostemsavir led to improvement in virologic suppression and immunologic response in such patients.
ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer PFE. The company plans to submit regulatory applications for fostemsavir in Europe during the coming months.
Shares of Glaxo have rallied 18.3% so far this year, outperforming the industry’s increase of 7%.
Meanwhile, Glaxo’s long-acting, injectable two-drug HIV regimen of cabotegravir plus J&J’s JNJ Edurant (rilpivirine) is under priority review in the United States with decision expected on Dec 29, 2019 from the FDA. The candidate is also under review in Europe.
Moreover, in April, Glaxo gained FDA approval for Dovato, a single tablet regimen of Tivicay (dolutegravir) + lamivudine for treatment-naïve HIV patients. Later, it was also approved in the EU in July. The new HIV medicine is off to a strong start in both the United States and the EU.
We remind investors that HIV is a key therapeutic area for Glaxo with successful dolutegravir-based regimens, namely Tivicay, Triumeq and Juluca in its portfolio. HIV sales totaled £3.6 billion in the first nine months of 2019. Upon potential approval, new medicines should further boost sales of the HIV franchise.
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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