AbbVie submits Rinvoq applications to FDA, EMA for psoriatic arthritis
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AbbVie has submitted applications to the FDA and European Medicines Agency for Rinvoq to include an indication for treatment of adult patients with active psoriatic arthritis, according to a press release.
Rinvoq (upadacitinib), a selective and reversible JAK inhibitor, showed noninferiority to adalimumab in terms of ACR20 response at 12 weeks in two phase 3 studies, the release said. Patients treated with Rinvoq also showed greater physical function and skin symptom improvements.
“Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness,” Michael Severino, MD, vice chairman and president of AbbVie, said in the release. “We look forward to working with regulatory authorities and hope to bring Rinvoq to people living with this debilitating disease as quickly as possible.”
Rinvoq is currently FDA approved for the treatment of adult patients with moderate to severe rheumatoid arthritis who have responded inadequately or are intolerant to antirheumatic drugs.
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