Pfizer receive European approval for arthritis drug
pharmafile | March 27, 2017 | News story | Sales and Marketing | Pfizer, rheumatoid arthritis
Following on from the positive opinion given to Xeljanz in January of this year, Pfizer’s drug has now been given European Commission marketing authorisation for treatment of moderate to severe active rheumatoid arthritis (RA).
The indication will be for patients who have responded inadequately to, or who intolerant to one or more disease-modifying antirheumatic drugs. The drug can also be given as a monotherapy when patients have intolerance to MTX or where treatment with MTX is inappropriate.
Xeljanz is a Janus kinase hibitor, part of a new class of therapies. It was initially rejected, back in 2013, but provided results from a further Phase 3 trial alongside real world data. The improved data package was enough to convince the European Commission to reverse its decision.
The treatment can now be supplied to a section of a treatment pool of more than 2.9 million sufferers of RA in Europe. RA is an inflammatory autoimmune disease that cause pain and swelling in the joints.
“With the approval of tofacitinib, rheumatologists and patients in the EU now have an additional treatment option for the management of rheumatoid arthritis that can be taken with or without methotrexate,” said Ronald van Vollenhoven, Professor of Rheumatology and Director of the Amsterdam Rheumatology and Immunology Center ARC. “This is an important advancement for the rheumatology community as up to one-third of people with rheumatoid arthritis may not achieve a response with current treatments and a number of patients may not sustain a response.”
Xeljanz is now approved for use in more than 80 countries worldwide.
Ben Hargreaves
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