AbbVie scoops up FDA approval for Rinvoq in moderately to severely active rheumatoid arthritis
pharmafile | August 19, 2019 | News story | Sales and Marketing | AbbVie, FDA, Rinvoq, pharma, rheumatoid arthritis
The FDA has awarded marketing authorisation to AbbVie’s Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis, it has emerged, in adult patients who have shown inadequate response or intolerance to methotrexate (MTX).
Data submitted in support of the application was drawn from one of the largest Phase 3 trial programmes in this indication, encompassing around 4,400 patients across five studies; Rinvoq met all primary and ranked secondary endpoints across these studies.
Specifically, it was found that 52% of MDX–naïve patients achieved a score of 20 on the American College of Rheumatology (ACR) response criteria, representing a 20% improvement in symptoms after 12 weeks compared to 28% of those receiving MTX alone. At this same point in the trial, 71% of patients inadequately responding to MTX achieved ACR20 compared to 36% of those taking placebo plus MTX.
Around 30% of Rinvoq patients achieved clinical remission at week 12 in one trial and at week 14 in another compared to 6% with placebo plus MTX and 8% with methotrexate, respectively.
“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,” explained Dr Roy M Fleischmann, a Primary Investigator on one of the trials and Clinical Professor at the University of Texas Southwestern Medical Center. “With this FDA approval, Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”
The manufacturer plans to launch the therapy in the US in late August 2019, when it will be available for $59,000.
Matt Fellows
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