SanofiSNY and Regeneron Pharmaceuticals, Inc. REGN announced that their pipeline candidate, sarilumab, has been approved in Canada for the treatment of adult patients with moderate-to-severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Sarilumab, to be marketed under the trade name Kevzara, is expected to be available to patients in Canada soon.
Sarilumab is still under review in the U.S and the EU, with regulatory decisions expected later this year.
The Canadian approval was supported by data from the global SARIL-RA clinical study, conducted in approximately 2,900 adults with moderate-to-severely active RA. Kevzara demonstrated clinically meaningful improvements, both as monotherapy and in combination with conventional DMARDs, including methotrexate.
Shares of Sanofi have significantly outperformed the Zacks classified Large Cap Pharma industry in the last six months. The stock lost 1.9% during the period, while the industry registered a decline of 13.9%.
We note that in Oct 2016, the companies got a Complete Response Letter (CRL) from the FDA for sarilumab. While the CRL did not raise any issues regarding sarilumab's efficacy or safety, the agency cited certain deficiencies observed during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished. Sanofi has submitted a comprehensive corrective action plan to the FDA and is working on implementing corrective actions.
Resubmission of sarilumab's Biologics License Application (BLA) to the FDA is expected in the first quarter of 2017. The resubmission, however, depends on successful completion of an inspection of the Le Trait facility by the FDA, with an anticipated action date in the second quarter of 2017.
Meanwhile, the European Medicines Agency accepted the companies' marketing authorisation application for sarilumab for review in Jul 2016.
Note that Pfizer, Inc.'s PFE Xeljanz is already approved for the treatment of moderate-to-severely active RA in patients who respond inadequately or are intolerant to methotrexate. Other drugs approved for RA include Roche Holding AG's RHHBY Actemra and Bristol-Myers Squibb's Orencia.
Sanofi 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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