Expansion on the horizon for Pfizer's Xeljanz

Dive Brief:

Successful results from two clinical trials are encouraging news for Pfizer's drive to expand the indications for its rheumatoid arthritis drug, Xeljanz, into ulcerative colitis and psoriatic arthritis.
Pfizer is set on realizing the drug's rising star potential. Xeljanz's sales increased by nearly 70%, or $100 million, last quarter, compared to a similar period last year, making it the company's second-fastest growing drug behind the oncology drug Ibrance.
The drug's market potential appears to be expanding, too. Express Scripts, one of the largest pharmacy benefits managers in the U.S., revealed this week it would take Xeljanz off its drug exclusion list. And in March, the European Medicines Agency accepted the company's marketing application to use Xeljanz to treat rheumatoid arthritis.

Dive Insight:

Pfizer's plan for Xeljanz (tofacitinib) suffered a setback last year after a complete response letter from the Food and Drug Administration prompted the company to withdraw all pending regulatory applications for a moderate-to-severe plaque psoriasis indication. Yet, the anti-inflammatory drug is poised to enter other indications.

Xeljanz is the first once-daily,oral janus kinase (JAK) inhibitor and is set to enter many of the other anti-inflammatory markets that are typically dominated by older TNF blockers and generic copies of those blockbusters. Pfizer faces the particular challenge of competing with these low-cost -- but injectible -- alternatives.

Pfizer inched closer to that goal this summer through the OPAL Beyond and OCTAVE Sustain trial results that were announced in June and July, respectively. Both trials met their primary endpoints and the drug showed statistically significant efficacy for the treatment of psoriatic arthritis and ulcerative colitis when compared to a placebo using 5mg and 10mg twice daily treatments.

"We are very bullish on the opportunity with Xeljanz," said Albert Bourla, group president of Pfizer Innovative Health. "We are confident in the value of Xeljanz because we are the first-in-class JAK inhibitor. The ongoing data dissemination that's expressed in real-world experience continues and will provide significant growth.