Escalate Life Sciences
Bristol Myers gets FDA approval for new type of psoriasis drug.
Sotyktu targets a protein called TYK2 and has been one of the pharmaceutical company’s top pipeline candidates.
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, Sotyktu’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.
Read the original article in https://www.biopharmadive.com/news/bristol-myers-tyk2-fda-approval-sotyktu-psoriasis/631577/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-09-12%20BioPharma%20Dive%20%5Bissue:44442%5D&utm_term=BioPharma%20Dive
Published Sept. 10, 2022 • Updated Sept. 12, 2022
Written for Jonathan Gardner, Senior Reporter | @ByJonGardner