Short on label expansions, Pfizer nabs FDA OK for new, once-daily Xeljanz

Pfizer ($PFE) has so far come up short in its quest to expand Xeljanz into new diseases. But in the meantime, it's rolling out a new extended-release formula for the disease it's already approved to treat.

Wednesday, the FDA approved an extended-release formulation of Xeljanz, a second-line, oral rheumatoid arthritis therapy. Patients can now take the therapy once a day, as opposed to the two daily doses recommended for the older version.

While the thumbs up won't bring along a huge new patient pool, Pfizer will take any Xeljanz boost it can get. The therapy hauled in just $523 million in 2015, missing the blockbuster numbers industry watchers once predicted by a longshot.

Plus, if Xeljanz does end up carving out a market, the XR formula could keep the brand's sales coming after the original formula's patent expires. Extended-release versions are a common pharma tool for keeping a brand alive, as patients often switch to an XR version to avoid multiple daily doses.

The New York pharma giant had counted on an expanded Xeljanz label to fuel sales growth. The Wednesday approval follows a rockier regulatory decision for Xeljanz, which U.S. regulators last October turned down as a treatment for psoriasis. After the rejection, Pfizer said it would "reconsider" its investment in a psoriasis nod, and it nixed a couple of other Xeljanz development projects--in Crohn's Disease and ankylosing spondylitis--too.

Instead, Pfizer will be looking to pick things up in the rheumatoid arthritis market, and it's eyeing psoriatic arthritis and ulcerative colitis as new frontiers. In addition to launching the XR version, Pfizer's RA effort will include refiling its Xeljanz application in Europe, where it suffered a 2013 rejection at the hands of regulators.

That process has gone a bit more slowly than some analysts had expected, and on the company's Q4 conference call, CEO Ian Read acknowledged "somewhat of a slippage" on the European application. But that's because "we wanted to get it right and make sure that it was in the best shape we could," he told investors. And regardless, Pfizer expects "to have full support for Xeljanz when it launches in Europe."

- read the release
- see the call transcript

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