AbbVie announces extension of USFDA review period for Rinvoq sNDA

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

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

Rinvoq, which is discovered and developed by AbbVie scientists, is used for the treatment of adults and adolescents with moderate to severe atopic dermatitis.

The action date for the updated Prescription Drug User Fee Act (PDUFA) has been extended to early third quarter of this year.

Recently, the company has also received a similar request from the USFDA regarding sNDA for upadacitinib for the treatment of adults with active psoriatic arthritis.

As mentioned previously, the USFDA sent an information request for an updated assessment of the benefit-risk profile for upadacitinib in atopic dermatitis, to which the company has already responded.

The USFDA is yet to give a full review of the submission.

AbbVie vice-chairman and president Michael Severino said: “We are confident in the sNDA and continue to work with the FDA to bring upadacitinib to patients living with moderate to severe atopic dermatitis in need of new treatment options.”

RINVOQ is a JAK inhibitor, which is used for adult patients with moderate to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Approved by the European Commission, the upadacitinib is also used for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs.

The side effects of the medicine include lowering the immune system’s ability to fight infections, including serious infections such as tuberculosis (TB) and infections caused by bacteria, fungi, or viruses, which can spread throughout the body.

This is not a CAPTIS article. Originally, it was published here.