Pfizer Inc. PFE announced that its Marketing Authorisation Application (MAA) for Xeljanz (5 mg tablets, twice daily) has been accepted for review by the European Medicines Agency (EMA) for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who have showed inadequate response or intolerance to methotrexate (MTX).
The resubmitted MAA covers additional information, including results from the phase III ORAL global development program in RA.
We remind investors that in Jul 2013, the Committee for Medicinal Products for Human Use (CHMP) of the EMA had recommended against the approval of Xeljanz for the treatment of adults with moderate to severely active RA. The committee opined that the drug had failed to demonstrate a favorable benefit-risk profile. It had also stated underlying concerns related to safety as well as serious infections.
We note that in Nov 2012, Xeljanz (5 mg twice daily) was approved in the U.S. for the treatment of adults with moderate to severely active RA, on whom MTX did not work well. The drug was approved for use as monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Then in Feb 2016, the FDA approved an extended-release 11 mg tablet for the once-daily formulation of Xeljanz. The drug is currently approved in over 45 countries for the RA indication. In 2015, the company generated worldwide Xeljanz sales of $172 million, up 65.4% from 2014.
According to information provided by the company, approximately 23.7 million individuals in the world and 1.6 million individuals in the U.S. are affected by RA.
Drugs currently approved to treat RA include Actemra, Cimzia and Orencia among others.
Pfizer currently has a Zacks Rank #3 (hold). A few of better-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. AMAG, Emergent BioSolutions, Inc. EBS and Anika Therapeutics Inc. ANIK, each sporting a Zacks Rank #1 (Strong Buy).
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