“We believe Sotyktu is a breakthrough in the treatment of patients suffering from moderate-to-severe plaque psoriasis,” said Bristol Myers’ chief medical officer Samit Hirawat.
The U.S. Food & Drug Administration gave its approval to Sotyktu, the first new treatment for adults suffering from moderate-to-severe plaque psoriasis in more than ten years, following data from a late-stage study of around 1,684 patients.
The drug, which Bristol Myers said could launch as early as this month, is expected to challenge the $2.3 billion market current controlled by Amgen’s (AMGN) – Get Amgen Inc. Report Otezla therapy. Sotyktu is slated to price at around $6,164 for a 30-day treatment, compared to around $4,344 for Otezla.
“The approval of Sotyktu represents an exciting day for patients suffering from moderate-to-severe plaque psoriasis who are not satisfied with topical and conventional treatments,” said Bristol Myers’ chief medical officer Samit Hirawat. “This is another extraordinary achievement for Bristol Myers Squibb, as we bring forward a new mechanism of action, the first oral treatment approved in nearly 10 years, and the first orally dosed once-daily treatment for moderate-to-severe plaque psoriasis.”
“We believe Sotyktu is a breakthrough in the treatment of patients with this condition, and we’re excited about its potential in other immune-mediated diseases,” Hirawat added.
Bristol Myers shares were marked 6.8% higher in pre-market trading to indicate an opening bell price of $74.92 each. Amgen shares, meanwhile, fell 1.02% to $245.16 each.
Bristol Myers boosted its full-year profit forecast in late July to a range of between $4.20 to $4.30 per share following better-than-expected second quarter earnings that were powered in part by a 24% surge in its Eliquis blood clot treatment.
Bristol-Myers said non-GAAP earnings for the three months ending in June came in at $1.18 per share, up 16.8% from the same period last year and 10 cents ahead of the Street consensus forecast. Group revenues, Bristol-Myers said, rose 10.52% to $6.3 billion and again topped analysts’ estimates of $5.72 billion.
A mid-stage trial of its developing stroke treatment, an anticoagulant known as milvexian however, failed to meet the primary goal of the study even as it showed a 30% relative risk reduction, and a safety profile, when compared to placebos.