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March 27, 2017

EC approves Pfizer’s Xeljanz to treat rheumatoid arthritis in EU

The European Commission (EC) has approved Pfizer's Xeljanz (tofacitinib citrate) oral tablets to treat moderate-to-severe active rheumatoid arthritis (RA) in adult patients in the European Union (EU).

The European Commission (EC) has approved Pfizer's Xeljanz (tofacitinib citrate) oral tablets to treat moderate-to-severe active rheumatoid arthritis (RA) in adult patients in the European Union (EU).

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The 5mg twice-daily (BID) tablets have been approved in combination with methotrexate (MTX) for patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Xeljanz belongs to a new class of therapies called Janus kinase (JAK) inhibitors, and can be given as monotherapy in case of intolerance to MTX, or when treatment with MTX is otherwise inappropriate.

Pfizer Innovative Health Inflammation & Immunology regional president Angela Lukin 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.”

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

The approval decision was based on results received from the Phase III Oral Rheumatoid Arthritis trials (ORAL) global development programme and real world data.

Xeljanz is now approved for prescription in more than 80 countries worldwide, and Pfizer is now working with the appropriate authorities in EU countries to support reimbursement and availability of the tablets.

RA is a chronic, inflammatory autoimmune disease that causes a range of symptoms such as pain and swelling in the joints, particularly those in the hands, feet and knees.

Tofacitinib is included in several RA treatment recommendations, including those published by the European League Against Rheumatism (EULAR), the American College of Rheumatology (ACR) and Asia Pacific League of Associations for Rheumatology (APLAR).


Image: Xeljanz 5mg bottle. Photo: courtesy of Business Wire.

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Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
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