Pfizer appealing CHMP ruling on RA treatment Xeljanz

Pfizer has big expectations for its oral rheumatoid arthritis treatment Xeljanz--about $3 billion worth. But those expectations were struck a serious blow when European Medicines Agency (EMA) regulators Thursday turned it down for approval. 

The EMA's Committee for Medicinal Products for Human Use (CHMP) said the drug improved arthritis symptoms and patients' functions but didn't sufficiently interrupt the advance of the disease or damage to joints. Pfizer ($PFE) didn't take the news lightly, Reuters reports, firing back it would "immediately seek a reexamination of the opinion."

The FDA last year approved Xeljanz, one of Pfizer's best bets for restoring some of the revenue lost from the one-time world's best-selling drug, cholesterol fighter Lipitor. But it wasn't completely smooth sailing before the FDA. The agency delayed consideration for three months to better analyze some additional data that Pfizer submitted in hopes of winning approval. 

The treatment carries a list price of $2,055 per 30-day supply, or about $24,000 per year, and analysts have pegged peak sales at between $2.5 billion and $3 billion. Those forecasts, however, factor in anticipated sales in the EU market. Mark Schoenebaum, an analyst with International Strategy & Investment Group in New York, estimated to Bloomberg that the EU would account for about $510 million in sales by 2018. 

Xeljanz is up against some notable competition, including the market leader and world's current best-selling drug, AbbVie's ($ABBV) Humira. There is also Remicade from Johnson & Johnson ($JNJ) and even Enbrel, which Pfizer has been co-marketing with Amgen ($AMGN) under a deal set to expire next year. Regulators noted that Xeljanz comes with some heavy-duty risks, but so do its competitors. Besides the boxed warning on Xeljanz's label, the FDA is requiring Pfizer to conduct a post-marketing study to gauge the drug's risks of heart disease, cancer and serious infections in two doses, the 5 mg dose the FDA approved and the 10 mg dose it didn't.

But as PharmaTimes points out, Xeljanz has something going for it that its competitors do not. They have to be injected, and Xeljanz is the first new oral non-biologic disease-modifying antirheumatic drug (DMARD) to be available in more than 10 years.  

- here's the Reuters story
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