Home » FDA Delays Decision Over AbbVie’s Rinvoq for Psoriatic Arthritis
FDA Delays Decision Over AbbVie’s Rinvoq for Psoriatic Arthritis
The FDA has extended its review period for AbbVie’s supplemental New Drug Application for Rinvoq (upadacitinib) as a treatment for adults with psoriatic arthritis.
The agency’s Prescription Drug User Fee Act-mandated target action date will now be three months later, set for the end of this year’s second quarter.
AbbVie disclosed it had received a recent FDA request for an updated assessment of the drug’s risks and benefits, and that it sent a response, which means the agency “will require additional time for a full review of the submission.”
Rinvoq is well on its way to becoming a blockbuster drug. AbbVie earned $731 million in Rinvoq sales globally in 2020.
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