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Roche’s Rituxan Gets Priority Review for Label Expansion


Roche Group’s RHHBY member Genentech announced that the FDA accepted Supplemental Biologics License Application (sBLA) and granted Priority Review for the label expansion of the company’s leukemia drug Rituxan (rituximab). The company is seeking to get Rituxan approved for the treatment of pemphigus vulgaris, which is a life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

Rituxan is already approved for treating blood cancers including non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia as well as immunological diseases like rheumatoid arthritis.

Priority Review designation from the FDA is generally granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.

Over a year, shares of Roche have declined 3% as against the industry’s growth of 10.1%.

The sBLA submission was based on data from a Roche-supported randomized trial conducted in France which evaluated Rituxan plus a tapering regimen of low dose oral corticosteroid (“CS”) treatment compared with a standard dose of CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. The study showed that Rituxan provides considerable improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy.

However, we remind investors that competition from Amgen’s AMGN and Novartis’ NVS biosimilars loom large on Rituxan.

Zacks Rank & Stock to Consider

Roche carries a Zacks Rank #3 (Hold).

A better-ranked stock from the health care space is Exelixis EXEL, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Exelixis’ earnings per share estimates have moved up from 72 cents to 77 cents for 2018 in the last 60 days. The company delivered positive earnings surprise in the last four quarters, with an average beat of 572.92%. Share price of the company surged 30.8% over a year.

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