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Earlier this month, the FDA slapped down Pfizer's ($PFE) Xeljanz as a treatment for moderate to severe cases of plaque psoriasis. And that could be the end of the line for the med in that indication, execs said Tuesday.
Pfizer will "reconsider" its investment in a psoriasis nod for Xeljanz following discussions with the FDA, CEO Ian Read told investors on the company's Q2 conference call. "We recognize that overcoming the issues raised" by the agency "may be difficult, especially in light of the evolving marketplace."
That marketplace includes a host of new psoriasis contenders coming up through Big Pharma's pipelines. Novartis' ($NVS) Cosentyx, the leader of the pack, won approval earlier this year, and Merck & Co. ($MRK), Johnson & Johnson ($JNJ), Eli Lilly ($LLY) and others have prospective meds that could soon prove tough contenders.
And in the meantime, Pfizer is nixing a couple of other development projects for Xeljanz, too, halting work with the drug in Crohn's Disease and ankylosing spondylitis. Novartis already has regulatory submissions out for Cosentyx in ankylosing spondylitis, an area where J&J is looking to compete with its Stelara, too. And Stelara--itself under fire from the new psoriasis competition--recently posted positive Phase III data in Crohn's patients who had failed first-line therapy.
Instead, Pfizer will be relying on Xeljanz' current indication--rheumatoid arthritis--plus psoriatic arthritis and ulcerative colitis to help the slow starter get going. Xeljanz has racked up just $351 million in sales through the first 9 months of this year, meaning it'll fall far from the blockbuster numbers industry watchers once predicted.
In ulcerative colitis, though, Pfizer has some promising data in hand. Two studies--OCTAVE 1 and 2--both met their primary endpoints, measured by the proportion of Xeljanz patients in remission after 8 weeks of treatment compared with patients on placebo, the company said last month. Those trials are part of a group of four expected to form a potential regulatory submission package for a UC nod.
And the drugmaker is still testing Xeljanz in RA, too; it's working on a head-to-head superiority study that pits the therapy against the world's best-selling med, AbbVie's ($ABBV) Humira, Pfizer's pharma president, Geno Germano, told investors on the call. Pfizer expects to read out results in the first quarter of 2017.
- read Pfizer's release (PDF)
- see the call transcript
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