It’s been a year of ups and downs for Pfizer’s Xeljanz. But the New York drugmaker is hoping to close on a high note with help from the FDA, which Thursday approved a new, more convenient version of the drug.
Regulators cleared the new extended-release product, known as Xeljanz XR, at 11mg and 22mg strengths for adult patients with ulcerative colitis. And unlike its predecessor pill, which patients take twice per day, the long-acting version only needs to be taken once daily.
Pfizer was quick to point to the convenience advantage, citing the disease’s ability to “significantly affect a patient’s quality of life and be emotionally burdensome due to symptoms, flares and complications,” as Michael Corbo, Pfizer Global Product Development’s Chief Development Officer for inflammation and immunology, put it in a statement.
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It’s a familiar tune for the drugmaker, which has long been playing up the convenience factor of Xeljanz—a pill—against its injectable rivals. And that edge may have helped it grow sales through the first nine months of the year to $1.63 billion, up from $1.22 billion over the same period last year.
But back in July, Pfizer got some bad news from the FDA: The agency decided to add a Black Box warning—its most serious—of increased blot clots to the Xeljanz label and to restrict its use to patients who have already tried or aren’t candidates for other meds.
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Just how much the limitations wind up hurting Pfizer’s sales remains to be seen—but in the meantime, the company also has new competition to worry about. The FDA in October green-lighted Johnson & Johnson stalwart Stelara in the indication, and AbbVie newcomer Skyrizi—the follow-up to anti-TNF blockbuster Humira—is currently in phase 3 ulcerative colitis trials.