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Pfizer's Rheumatoid Arthritis Drug – Xeljanz gets approval from the EU

Apr 11, 2017

Pfizer's Rheumatoid Arthritis Drug – Xeljanz gets approval from the EU

The European Commission (EC) has green-lighted Xeljanz (tofacitinib citrate) oral tablets from Pfizer for treating moderate-to-severe active rheumatoid arthritis (RA) in grown-up patients in the European Union (EU).

Xeljanz is a 5mg twice daily oral tablet which the EU has approved and is to be used in tandem with methotrexate (MTX) for treating moderate-to-severe rheumatoid arthritis (RA). It is meant for people who are not tolerant to or previously responded insufficiently to either one or more disease-modifying anti-rheumatic drugs (DMARDs).

The drug can also be given as a monotherapy incase the patient is intolerant to MTX. Methotrexate is the most common rheumatoid arthritis treatment, which reduces pain, inflammation and swelling and additionally slackens the disease’s progression. Xeljanz is a part of a novel class of therapeutics known as Janus kinase (JAK) inhibitors.

Angela Lukin who is Pfizer Innovative Health Inflammation & Immunology regional president said - “With a heritage of more than 60 years of providing rheumatoid arthritis treatment options, Pfizer has been a leader in helping to improve the lives of people with inflammatory conditions.

“The approval of Xeljanz in Europe demonstrates Pfizer’s ongoing commitment to developing medicines that address unmet needs for people living with chronic conditions like rheumatoid arthritis.”

Depending upon the resultants gotten from real world data and the Phase III Oral Rheumatoid Arthritis trials (ORAL) global development study that depicted the safety and efficiency of Xeljanz, both including MTX and without it, the entire approval decision by the European Commission was taken.

This medicinal drug is not approved for prescription use in more than 80 countries across the world which includes the United States, where it was primarily approved in November 2012. Pfizer is currently working with suitable authorities in EU countries to back compensation and availability of the tablets.

Rheumatoid arthritis is a chronic, inflammatory autoimmune disease which affects more than 17 million individuals across the globe, and more than 2.9 million in Europe alone. The disease leads to variety of symptoms including pain and swelling in the joints like feet, knees and hands.

Xeljanz drugs functions inside the human cells to obstruct a signaling trail, which is thought to be the reason behind the inflammation in the moderate to severe active rheumatoid arthritis.

AbbVie Inc.’s (ABBV) Humira, and Amgen Inc.’s (AMGN) biosimilar Amjevita, Regeneron Pharmaceuticals Inc. (REGN) and Sanofi SA’s (SNY) sarilumab are other available therapies which are competing the market shares.

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