Rinvoq FDA approval : US biopharma company AbbVie has bagged approval from the US Food and Drug Administration (FDA) for its 15mg, daily once oral, small molecule Janus kinase (JAK) inhibitor – Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis (RA).

The FDA approval for Rinvoq is for the treatment of rheumatoid arthritis patients who showed inadequate response or intolerance to methotrexate (MTX-IR), as per the latest FDA drug approval news.

AbbVie expects to launch the newly approved rheumatoid arthritis drug Rinvoq in the US later this month.

Rinvoq, which was discovered and developed by AbbVie, is now the second targeted immunomodulator (TIM) therapy of the company to be approved by the FDA this year after SKYRIZI (risankizumab-rzaa), which has been approved for the treatment of moderate to severe plaque psoriasis.

AbbVie bags Rinvoq FDA approval for rheumatoid arthritis. Photo courtesy of AbbVie Inc.

Michael Severino – vice chairman and president of AbbVie, commenting on Rinvoq FDA approval, said: “The discovery and development of Rinvoq is indicative of AbbVie’s long-standing commitment to advancing the science for people living with immune-mediated conditions.

“Today’s FDA approval marks an important milestone in our pursuit to deliver innovative medicines that advance care for people living with rheumatoid arthritis.”

Rinvoq FDA approval is backed by the findings of the SELECT phase 3 program featuring nearly 4,400 patients assessed across all treatment arms in five studies. In all the SELECT phase 3 clinical trial, Rinvoq achieved all primary and key secondary endpoints.

Commenting on Rinvoq FDA approval, Roy M. Fleischmann – primary investigator for SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at Dallas, said: “Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis.

“With this FDA approval, Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”

Rinvoq is being reviewed by the European Medicines Agency (EMA), and also regulatory authorities in Canada and Japan, for the treatment of moderately to severely active rheumatoid arthritis in adult patients.

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