FDA approves Pfizer’s Cibinqo for adolescent atopic dermatitis

Pfizer (NYSE:PFE) has announced that the FDA has approved its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) for moderate-to-severe atopic dermatitis. The approval expands the indication for the drug, which was previously only approved for adults with the skin condition in early 2022.

The expanded indication includes adolescents between the ages of 12 and 18 whose disease is not adequately controlled with other systemic drugs or when their use is inadvisable.

Cibinqo is a potential blockbuster

In 2020, Pfizer had estimated that abrocitinib would eventually garner $3 billion in peak annual sales.

The company is also investigating its potential in prurigo nodularis and pruritus.

The systemic JAK inhibitor is in the same class as baricitinib from Incyte and Lilly and upadacitinib from AbbVie.

The FDA updated the prescribing information for Cibinqo to include data from the JADE TEEN clinical trial, which evaluated the 100 mg…

Read more
  • 0

FDA approves Pfizer’s JAK1 inhibitor Cibinqo for moderate-to-severe atopic dermatitis

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.

Read more
  • 0