EC green light for Pfizer's Xeljanz in AS

The European Commission has approved Xeljanz (tofacitinib) 5mg twice daily for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

Xeljanz, marketed by US pharma giant Pfizer (NYSE: PFE) and already notching up annual sales of $2 billion, is the first and only oral Janus kinase (JAK) inhibitor approved for five indications in the European Union (EU), including in adults with moderate to severe active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with moderately to severely active ulcerative colitis (UC), and patients 2 years of age or older with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile psoriatic arthritis (PsA).

“Ankylosing spondylitis is a debilitating and chronic immuno-inflammatory disease that affects the lives of more than one million people in the EU who are in need of additional treatment options,” said Ana Paula Carvalho, international developed markets regional president, inflammation and Immunology at Pfizer.