Bristol Myers stock rises on FDA approval of psoriasis therapy Sotyktu; presents long-term efficacy data
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(Editorâs note: The article was updated with analysts' comments on the drug not getting a black-box warning.)
The U.S. Food and Drug Administration (FDA) on Sept. 9 approved Bristol Myers Squibb's (NYSE:BMY) Sotyktu, and avoided JAK inhibitor-like boxed warning, to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The company said Sotyktu is not recommended for use in combination with other potent immunosuppressants.
Sotyktu (deucravacitinib) is an allosteric inhibitor of tyrosine kinase 2 (TYK2), which is a member of the Janus kinase (JAK) family.
Wells Fargo analysts said that going into the approval, the discussion was that if Deucrava would get a JAK inhibitor-like class label warning related to malignancies and CV risks.
The drug avoiding a black-box warning removed a bear case scenario but the firm doubted if bull case has played out as there were still biologics-like testing requirements for TB and triglycerides, which Amgen's (AMGN) Otezla does not have.
The firm thinks it could be an obstacle for adopting the drug but Bristol Myers noted that dermatologists are used to these tests and given biologics have similar requirements, BMY does not expect this to be a hindrance.
The firm noted that they think this label appears to be a middle ground where physician preference and comfort level may come into play and overall, see the label as better than consensus expectations and in line with the firm's 50/50 probability of class label.
Bristol Myers said in the Sept. 9 press release that the approval was backed by data from phase 3 trials called POETYK PSO-1 and POETYK PSO-2.
In a separate Sept. 10 release, Bristol Myers reported two-year data from the POETYK PSO long-term extension (LTE) trial showing clinical efficacy was maintained with continuous Sotyktu treatment in adult patients with moderate-to-severe plaque psoriasis.
Out of the 262 patients receiving Sotyktu in the analysis, 171 had achieved Psoriasis Area and Severity Index (PASI) 75 (a 75% reduction in the disease area and severity) at week 16 of the POETYK PSO-1 trial, and among these patients, efficacy was maintained for up to 112 weeks, including response rates for PASI 75 (week 16 - 100%; Week 52 - 90.1%; week 112 - 91.0%). PASI 90 (week 16 - 62.6%; week 52 - 64.9%; week 112 - 63.0%), according to the company.
Static Physicians Global Assessment (sPGA - estimate of a patient's overall severity of disease) 0/1 (week 16 - 84.2%; week 52 - 73.7%; week 112 - 73.5%).
"These two-year follow-up data demonstrate the durable efficacy offered by Sotyktu and its potential to provide long-term, clinically relevant improvement for individuals with moderate-to-severe plaque psoriasis," said Jonathan Sadeh, senior vice president of Immunology and Fibrosis Development, Bristol Myers.
BMY +6.19% to $74.50 premarket Sept. 12