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March 17 – Abbvie Inc. said the U.S. Food and Drug Administration has extended the review period for the extended use of its Rinvoq rheumatoid arthritis drug by three months, citing the need for more time to assess the risk-benefit profile. of the medicine.
The pharmaceutical company’s shares fell 7.04% to $ 103.8 at the beginning of the session.
Abbvie said on Wednesday that the U.S. health agency was considering requesting 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 about to lose patent protection in 2023 for its successful drug Humira in the United States, its largest market.
The drugmaker said it responded to the U.S. agency’s request for additional details about the drug’s risk-benefit profile, adding that the FDA would need more time for a complete review of the request.
The 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)