Pfizer (NYSE:PFE) has announced that the FDA has approved the oral Janus kinase 1 inhibitor Cibinqo (abrocitinib) for adults with refractory, moderate-to-severe atopic dermatitis (AD).
In 2020, Pfizer CEO Dr. Albert Bourla projected that Cignqo would generate $3 billion in peak sales. In 2021, SVB Leerink projected the drug would generate $2 billion in sales by 2027.
The agency also approved AbbVie’s (NYSE:ABBV) JAK inhibitor Rinvoq for patients with moderate-to-severe atopic dermatitis who are at least 12 years old.
Both approvals are limited to patients who fail to find adequate relief from other drugs or in cases when the use of other medications is inappropriate.
Last year, FDA recommended that JAK inhibitors have updated safety warnings given a potentially elevated risk of cardiovascular complications in patients taking such drugs.
FDA approved 100- and 200-mg doses of Cibinqo with a 50-mg option available for certain patients.
Ciginqo won approval in Europe in December 2020 for patients with moderate-to-severe atopic dermatitis. In September 2020, the drug won approval in the UK.
The FDA reviewed data from five clinical trials involving a total of more than 1,600 patients.
“Cibinqo, an efficacious once-daily pill, is a medical breakthrough made possible by Pfizer researchers and the people living with moderate-to-severe atopic dermatitis who participated in our clinical trials,” said Mike Gladstone, global president of Pfizer inflammation and immunology.
Abrocitinib has been the focus of 32 clinical trials, according to AdisInsight.