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Glaxo Files Marketing Application for Fostemsavir in Europe

Zacks Equity Research

GlaxoSmithKline plc’s GSK HIV subsidiary ViiV Healthcare announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its first-in-class attachment inhibitor fostemsavir to treat heavily treatment-experienced adult patients with HIV-1 infection.

The company is seeking approval of fostemsavir for use in combination with other antiretroviral agents to treat adult patients with multidrug resistant HIV-1 infection, for whom it is otherwise not possible to form a suppressive regimen due to resistance, intolerance or safety considerations.

Notably, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted an accelerated assessment to the MAA filing for fostemsavir, which reduces the review time for the same.

The MAA 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 new drug application for fostemsavir in the United States was filed with the FDA in December 2019.

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

Shares of Glaxo have rallied 21.2% in the past year, outperforming the industry’s increase of 14.7%.

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.

Moreover, Glaxo gained FDA approval in April 2019 for Dovato, a single tablet regimen of Tivicay (dolutegravir) + lamivudine for treatment-naïve HIV patients. Later, it was also approved in the EU during July. The new HIV medicine is off to a strong start in both the United States and the EU.

However, last month, Glaxo faced a major setback when it received a complete response letter (CRL) from the FDA for its investigational long-acting injectable regimen of cabotegravir and Johnson & Johnson’s JNJ Edurant (rilpivirine) for the treatment of HIV-1 infection in virologically suppressed adults.

Zacks Rank & Key Pick

Glaxo currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large cap pharma sector is Eli Lilly and Company LLY, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Eli Lilly’s earnings estimates have moved 3.2% north for 2020 over the past 60 days. The stock has increased 20.3% in the past year.

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