FDA asks for more time to review new indication for Abbvie drug

March 18, 2021

The FDA has extended its review period for Abbvie’s would-be blockbuster, Rinvoq.

The JAK inhibitor has already been approved to treat rheumatoid arthritis in 2019 and now the company is hoping to expand its use to patients with psoriatic arthritis. Abbvie is also hoping that as its mega-seller, Humira, comes closer to falling off the patent cliff, drugs like Rinvoq will fill in the sales gap.

However, the agency has asked Abbvie to provide additional information on the benefit-risk profile of the drug. The FDA is also reviewing the use of Rinvoq for atopic dermatitis.

Read the full Reuters report.