Pfizer Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Pfizer.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday January 25, 2017 to Tuesday January 31, 2017.
Pfizer Gets Positive EMA Opinion on RA drug
Pfizer has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending its anti-arthritis drug, Xeljanz (tofacitinib citrate) 5-mg twice daily, for treating moderate-to-severe active rheumatoid arthritis (RA). The CHMP’s opinion will now be sent to the European Commission for final decision.
If approved, Xeljanz in combination with methotrexate will be indicated for treating moderate-to-severe active RA in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. Xeljanz can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
Tofacitinib is part of the Janus kinase (JAK) inhibitor class of medications, a new class of medicines for treating moderate-to-severe active RA, according to Pfizer.
Xeljanz has been approved for use in over 50 countries, but remains an investigational medicine in the EU and has not been approved for use.