The Food and Drug Administration on Friday approved Bristol Myers Squibb’s psoriasis pill Sotyktu, the first medicine of its type and the last of three potential blockbuster drugs the company sought to bring to market this year.
Sotyktu will compete with biologic drugs like AbbVie’s Humira and Amgen’s Enbrel, but as a pill could be more attractive to patients who don’t want to inject themselves regularly. Importantly, Sotkytu’s labeling doesn’t require patients to first try biologic drugs, giving doctors an opportunity to prescribe it widely.
Approval came after Phase 3 testing in which the pill, also known as deucravacitinib, was tested against a placebo as well as another oral therapy, Amgen’s Otezla. In patients with moderate-to-severe plaque psoriasis, Sotyktu outperformed both on two commonly used measures for assessing skin clearing: PASI and sPGA.
“All in all, the overall efficacy and safety profile as a new first-in-class agent for plaque psoriasis bodes well for it becoming the standard of care,” said Samit Hirawat, Bristol Myers Squibb’s chief medical officer, setting a high bar for his company’s commercial expectations.
The FDA’s decision also resolved a question that had been hanging over Sotyktu as it progressed through clinical trials. The drug works by blocking an enzyme called TYK2 that signals other immune proteins, which when overexpressed is associated with the characteristic rashes and itching of psoriasis.
TYK2 is from a family of proteins called Janus kinases, or JAKs. Other JAK inhibitors, when used in treating rheumatoid arthritis, have been linked to cardiovascular complications and cancer. The FDA has required warnings on the labels of JAK inhibitors like Pfizer’s Xeljanz and AbbVie’s Rinvoq.
Sotyktu will not carry such a warning, which could make physicians more likely to prescribe the pill. “The FDA has agreed with us that this is a new class,” Hirawat said. “We don’t have [cardiovascular] events in the studies.” He said Bristol Myers will continue to monitor study participants for any safety signals.
A clean safety record will be helpful as Bristol Myers plans to expand Sotyktu’s use in other autoimmune disorders. The company is testing it in psoriatic arthritis and Crohn’s disease, success in which could be necessary to achieve the $4 billion in peak sales that Bristol Myers has projected.
New medicines like Sotyktu are critical for Bristol Myers, which faces patent expirations later this decade for top-selling therapies like the blood thinner Eliquis and cancer drugs Opdivo and Revlimid. Analysts from Bernstein forecast that products with looming patent expirations account for 80% of Bristol Myers’ current revenue.
So far, Bristol Myers’ plans are proceeding apace. Two other drugs that company executives predict will reach $4 billion in revenue, the cancer immunotherapy Opdualag and the heart drug Camzyos, have also been cleared by the FDA this year.
Bristol Myers executives expect at least $25 billion in sales will come from new products in 2029. Investors and analysts currently estimate a much lower number, according to Bernstein analysts.
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