FDA Approves J&J, Glaxo HIV Drug, Roche Presents Data

Pipeline and regulatory updates were the focus this week with the FDA approving the first two-drug HIV treatment in the United States and the European Commission (“EC”) granting approval to Johnson & Johnson’s (JNJ – Free Report) Tremfya and expanding the label of Novartis’s (NVS – Free Report) Tasigna.

Recap of the Week’s Most Important Stories

J&J, Glaxo HIV Drug Gets FDA Nod: J&J and GlaxoSmithKline (GSK – Free Report) gained FDA approval for the first two-drug HIV treatment in the United States. Juluca combines two approved HIV drugs – Tivicay (50 mg) and Edurant (25 mg) – into a single, once-daily pill for the maintenance treatment of virologically suppressed HIV-1 infection. The companies expect to make the drug available in U.S. pharmacies from December 11.

Juluca marks the beginning of a new era in HIV treatment with other companies like Gilead also working on bringing better treatments to the market.

EU Nod for J&J Psoriasis Drug: Janssen-Cilag International NV, a J&J company, gained EU approval for its psoriasis drug, Tremfya, for use in adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Approval was expected considering the Committee for Medicinal Products for Human Use (“CHMP”) had adopted a positive opinion in September. The drug was approved in the United States earlier this year in July.

Although the psoriasis market is pretty crowded, about 125 million people across the world are estimated to suffer from psoriasis including 14 million Europeans. 20% of these cases are considered moderate to severe. Tremfya is currently in late-stage development for the treatment of psoriatic arthritis.

Johnson & Johnson is a Zacks Rank #2 (Buy) stock – you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Roche Presents Data on Hemophilia and Cancer Drugs: Roche (RHHBY – Free Report) presented positive data on its recently approved hemophilia drug, Hemlibra, from a late-stage study (HAVEN 3) in adults and adolescents (aged 12 years or older) with hemophilia A without inhibitors to factor VIII. The study met its primary endpoint as well as key secondary endpoints with Hemlibra significantly reducing bleeds.