Dive Brief:
- An experimental psoriasis drug developed by Bristol Myers Squibb maintained its effectiveness over more than a year of treatment in a clinical trial extension, the company reported Thursday as researchers presented the data at a European medical conference.
- The drug, a pill called deucravacitinib, helped more than half of patients achieve clear or near-clear skin following 60 weeks of treatment after enrollment in one of two studies. Bristol Myers previously reported the primary analysis of the two trials, which came after 16 weeks of treatment, while Thursday’s data was from a long-term extension that included some of the participants in those trials.
- Deucravacitinib is due a Food and Drug Administration approval decision by Sept. 10. Bristol Myers forecasts sales of $4 billion by 2029, which if achieved would help it withstand the expected loss of revenue from other drugs that are facing patent expiration, such as the blood-thinner Eliquis and the cancer immunotherapy Opdivo.
Dive Insight:
Many of the most effective drugs for psoriasis, such as Eli Lilly’s Taltz and Johnson & Johnson’s Tremfya, are injectable biologics. With the exception of Amgen’s Otezla, pills for psoriasis are mostly older, less effective treatments. Often patients with severe disease can only find relief if they progress to the injectable drugs.
A pill like deucravacitinib could therefore be an attractive option for many patients. Drugs which act similarly, such as AbbVie’s Rinvoq and Pfizer’s Cibinqo, have been approved for another autoimmune skin disorder, eczema, but deucravacitinib would be the first for psoriasis.
Researchers tested a 6 milligram once daily dose of deucravacitinib and measured participants in two ways: the extent and severity of lesions before and after treatment using an index called PASI, and a doctor assessment of severity called sPGA. At 60 weeks, 78% of patients taking deucravacitinib had their PASI score fall by 75% or more, and 59% had a score of 0 or 1 on sPGA, indicating clear or almost-clear skin.
The percentage of patients that recorded those scores was greater at 60 weeks than at 16 weeks. Bristol Myers didn’t announce numbers comparing deucravacitinib’s effectiveness at 60 weeks to a placebo or Otezla, as it did in the primary analysis after 16 weeks, however.
Gaining approval for deucravacitinib is important for Bristol Myers as well as its investors, who are looking ahead to key patent expirations later in the decade. It’s one of three drugs the drugmaker queued up for approval this year that the company expects to hit $4 billion in sales.
However, achieving that $4 billion mark for deucravacitinib will depend on how the FDA views its safety. Drugs in its class like Rinvoq, Cibinqo and Xeljanz, which work by blocking a family of enzymes called Janus kinases that help to stimulate inflammation, have been linked to higher rates of cardiovascular death when compared to biologic drugs. The FDA has placed warnings on the labels of those drugs.
“A similar label for deucravacitinib will be a commercial problem, especially in psoriasis, given the availability of alternative lower risk drugs,” Ronny Gal, an analyst at Bernstein research, wrote in a Jan. 27 note to clients.
