GlaxoSmithKline (NYSE:GSK) plc’s GSK HIV subsidiary, ViiV Healthcare, announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has rendered a positive opinion recommending approval for Rukobia (fostemsavir) to treat heavily treatment-experienced adult patients with HIV-1 infection.
The company is seeking approval of its first-in-class attachment inhibitor, Rukobia (600 mg, extended-release tablets), 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 anti-viral regimen.
The CHMP opinion was based on data from the pivotal phase III BRIGHTE study which evaluated the safety and efficacy of Rukobia in combination with an optimised background therapy (“OBT”) in the given patient population.
Data from the study showed that 60% of heavily treatment-experienced adult patients who received Rukobia with an OBT achieved and maintained viral suppression at 96 weeks of treatment.
ViiV Healthcare filed a marketing authorization application in January 2020. A final decision from the European Commission is expected in the coming months.
Notably, in July 2020, the FDA approved Rukobia for treating heavily treatment-experienced adult patients with HIV-1 infection.
Shares of Glaxo have plunged 20% so far this year against the industry’s increase of 4.2%.
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ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer PFE.
Notably, 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).
We remind investors that HIV is a key therapeutic area for Glaxo. However, rising competitive pressure coupled with shift within its portfolio toward two-drug regimens is hurting sales of Glaxo’s HIV business. HIV sales totaled £3.6 billion in the first nine months of 2020, reflecting an increase of only 1% year-over-year. Upon potential approval, new medicines should further boost sales of the HIV franchise.
Other key players in the HIV market are Gilead Sciences (NASDAQ:GILD) GILD, Merck MRK and AbbVie ABBV.
Zacks Rank
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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