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Roche Rituxan Label Expanded by FDA for Pemphigus Vulgaris

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Roche Holdings (RHHBY - Free Report) announced that the FDA has approved Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV).

Per the company, Rituxan is the first biologic therapy approved by the FDA for PV. We remind investors that the FDA had granted Priority Review, Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV.

Being an autoimmune blistering disease affecting the skin and mucous membranes, PF affects 30,000 to 40,000 people in the United States. As a result of this approval, Rituxan is now approved to treat four autoimmune diseases like rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and PV.

The approval was based on data from the Ritux 3 trial, which compared the Ritux 3 regimen (EU-approved rituximab product plus short-term corticosteroids [CS]) to CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. The results from the study showed that 90% of PV patients treated with the Ritux 3 regimen met the endpoint compared to 28% of PV patients treated with CS alone.

We note that Roche’s subsidiary, Genentech and Biogen (BIIB - Free Report) , have a collaboration agreement for Rituxan in the United States while Roche markets MabThera (brand name of Rituxan outside the United States) in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Approval of new drugs and a potential label expansion of existing drugs bode well for Roche, as its legacy drugs like Herceptin and MabThera are facing competition from biosimilars. Sales of MabThera/Rituxan were down 8% in the first quarter of 2018 as sales in Europe (down 44%) were adversely impacted by the market entry of biosimilars.

Roche’s stock has lost 9.3% in the last six months compared with industry’s decline of 2.2%.

 

Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/MabThera in Europe. Amgen (AMGN - Free Report) has also obtained FDA approval for a biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer.

Zacks Rank

Roche 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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