USFDA extends review period for AbbVie’s sNDA of upadacitinib

The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for upadacitinib.

The global R&D-based biopharmaceutical company’s new drug is used in the treatment of adult patients with active psoriatic arthritis.

Late Q2 of 2021 has been given as the action date for the updated Prescription Drug User Fee Act (PDUFA).

Recently, the USFDA sent an information request to AbbVie for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis, which AbbVie complied with. A full review of the submission is yet to be given by the USFDA.

AbbVie also received a similar, separate request from the USFDA regarding sNDA for upadacitinib in atopic dermatitis, which will be submitted to the FDA soon.

AbbVie vice-chairman and president Michael Severino declared: “We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases.”

Upadacitinib (RINVOQ) was discovered and developed by AbbVie scientists. It is an oral, once daily, selective and reversible JAK inhibitor prescribed to treat adults with moderate to severe rheumatoid arthritis. Safe use of RINVOQ for children under 18 has not yet been confirmed.

Side effects of RINVOQ include lowering the immune system’s ability to fight infections. Serious infections such as tuberculosis (TB), lymphoma and other cancers can happen to patients being treated with RINVOQ.