AbbVie Inc. (NYSE: ABBV) declared that FDA has made the decision regarding the supplemental New Drug Application (sNDA) for upadacitinib. FDA has decided that it will extend the review period for sNDA for upadacitinib.
Furthermore, the PDUFA action date has been expanded three months to early Q3 2021. Earlier, it has been disclosed that it has obtained a request for information from the FDA for up-to-date evaluation of the benefit-risk profile for upadacitinib in atopic dermatitis.
In response to the FDA’s request and FDA has notified ABBV that, as anticipated, it requires extra time for a complete review of the application is submitted. ABBV commented that the firm is assured in the sNDA and continues to work together with the FDA to bring in upadacitinib to sufferers.
Upadacitinib is used for the treatment of adults and adolescents with mild-to-severe allergic dermatitis. It was identified and created by AbbVie scientists. RINVOQ has got U.S. FDA authorization for adult sufferers in August 2019, with mild to serious active rheumatoid arthritis who have had an insufficient response or intolerance to methotrexate.