Pfizer Inc. PFE announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for the company’s marketing authorisation application (MAA) for its rheumatoid arthritis (RA) drug, Xeljanz (tofacitinib citrate; 5 mg twice daily).
Pfizer is looking to get Xeljanz, in combination with methotrexate (MTX), approved in the EU for the treatment of moderate-to-severely active RA in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).
Xeljanz is already approved as a second-line treatment for this indication. The drug may also be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. A once-daily formulation of Xeljanz was approved by the FDA in Feb 2016.
Shares of Pfizer have outperformed the Zacks classified Large Cap Pharma industry in the last one year. The stock gained 4.1% during the period, while the industry registered a decline of 2.4%.
The MAA was supported by data from the Oral Rheumatoid Arthritis phase III Trials (ORAL) global development program. The program consisted of six clinical trials and two open-label long-term extension (LTE) studies. The ORAL development program had collected more than 19,000 patient-years of drug exposure in over 6,100 patients with follow-up observations of up to eight years in one of the LTE studies.
Presently, Xeljanz is being evaluated in phase III studies for the treatment of ulcerative colitis.
We remind investors that in Jul 2013, the CHMP had recommended against the approval of Xeljanz for the treatment of adults with moderate-to-severely active RA. The committee was of the opinion that the drug had failed to demonstrate a favorable benefit-risk profile. It had also revealed underlying concerns related to safety as well as serious infections.
Xeljanz has been generating strong sales in the U.S. In the first nine months of 2016, it garnered revenues of $649 million, up an impressive 85% year over year.
According to information provided by the company, approximately 17.6 million individuals in the world and 2.9 million individuals in Europe are affected by RA. Hence, approval of the drug will provide the company access to a huge patient population affected by the disease.
Note that on the same day, the CHMP granted a positive opinion to Amgen, Inc.’s AMGN biosimilar version of AbbVie, Inc. ABBV Humira for the treatment of RA. Other drugs approved for this indication include Roche Holding AG’s RHHBY Actemra and Bristol-Myers Squibb’s Orencia.