Abbvie Inc said the U.S. Food and Drug Administration has extended the review period for expanded use of its rheumatoid arthritis drug Rinvoq by three months, citing the need for more time to assess the drug’s benefit-risk profile.
Shares of the drugmaker fell 7.04% to $103.8 in early trading.
Abbvie said on Wednesday the U.S. health agency was reviewing the application for the use of Rinvoq in patients with active psoriatic arthritis, a type of inflammatory arthritis.
The drug was approved for the treatment of rheumatoid arthritis in 2019.
Abbvie has been betting on Rinvoq as it is set to lose patent protection in 2023 for its blockbuster drug Humira in the United States, its biggest market.
The drugmaker said it had responded to the U.S. agency’s request for additional details on the benefit-risk profile of the drug, adding the FDA would require additional time for a full review of the application.
FDA is also reviewing the expanded use of Rinvoq in atopic dermatitis and has sought additional information, which Abbvie plans to provide shortly.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Amy Caren Daniel)