After a series of delays and a lengthy safety review, Pfizer is on the scene in atopic dermatitis with a blockbuster-to-be.
Friday, the FDA approved the New York drugmaker's oral daily JAK1 inhibitor Cibinqo to treat adults with moderate to severe atopic dermatitis who have not been able to get their disease under control with other medicines, including biologics, and for those who can't take other treatments.
The FDA nod comes after the agency's U.K. counterpart, the Medicines and Healthcare products Regulatory Agency, became the first regulator to approve the medicine last September. It also comes amid a monthslong FDA investigation into JAK inhibitor safety that tripped up several drug applications including Cibinqo's review.
The Friday approval covers Cibinqo in 100-mg and 200-mg doses, with the higher dose recommended for patients who don't respond to the 100-mg dose. The agency also approved a 50-mg dose for patients with moderate kidney failure or certain other patients.
Cibinqo's FDA label means that the drug won't directly challenge Sanofi and Regeneron's dominant Dupixent, which is generating annual sales of about 6 billion euros as of the third quarter of 2021. In a note to clients after the FDA approval, ODDO BHF analysts wrote that the drug "will be prescribed if [Dupixent] fails to adequately treat the condition."
They said the label is "very favorable" for Sanofi and project peak Dupixent sales of 10.3 billion euros.
Pfizer has some lofty sales goals of its own. The company thinks its drug can generate peak sales of $3 billion, with biopharma chief Angela Hwang telling investors last fall that the figure would only require an 8% market share of the systemic atopic dermatitis market.
The FDA approved the drug based on five clinical trials in more than 1,600 patients. Pfizer says its med showed improvements versus placebo across the trials in skin clearance, itch symptoms plus extent and severity of disease.
Cibinqo was originally set for an FDA decision last April, but the agency's safety examination of JAK inhibitors triggered a series of delays. Amid its classwide safety review, the agency delayed decisions on meds from AbbVie, Eli Lilly and more. Also Friday, AbbVie's Rinvoq scored its own approval in atopic dermatitis.
Editor's note: This story was corrected to reflect that Pfizer's drug is approved for patients who don't respond to other systemic medicines or for those who can't take other treatments.