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New Pill For Rheumatoid Arthritis Gets FDA Nod

Filed by KOSU News in Business.
November 7, 2012

In the Election Day scramble you might have missed that Pfizer got a new drug approved for rheumatoid arthritis.

Pfizer expects the twice-a-day pill called Xeljanz will be available in pharmacies later this month.

The drug won’t come cheap. The wholesale price will run about $2,000 for a month’s supply, the company says.

There are lots of other treatments for rheumatoid arthritis. There’s an inexpensive generic pill called methotrexate. And there are some pricier options — Remicade, Enbrel and Humira, to name three — that require a needle.

But this rheumatoid arthritis drug is the first one that works by blocking enzymes called janus kinases. They play a communication role inside the body and are involved in inflammation associated with rheumatoid arthritis.

Pfizer says Xeljanz (say zel-jans) costs less than the two leading brand-name rheumatoid arthritis treatments.

But not a lot less, according to data from health industry analyst Mark Schoenebaum at ISI Group. He figures a year of treatment with Xeljanz would run only $2,000 or so less than treatment with Enbrel or Humira.

Xeljanz is for patients with moderate-to-severe rheumatoid arthritis who either can’t tolerate or don’t respond to methotrexate, the Food and Drug Administration said.

In a presentation to investors, Schoenbaum wrote that he expected doctors to use the drug “cautiously” and mainly in patients who had failed Enbrel and Humira.

The new drug’s instructions come with a boxed warning, the most serious type of safety information required by FDA. Xeljanz carries a risk of serious infections, including tuberculosis and some illnesses that required hospitalization in clinical tests. The drug also raises cholesterol. It was also associated with an increased risk for some cancers.

Pfizer agreed to study those side effects in a long-term study. [Copyright 2012 National Public Radio]

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