AbbVie (ABBV) said Friday it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval of its Rinvoq drug for the treatment of giant cell arteritis in adults.
The positive opinion is based on results from the company's phase 3 clinical trial evaluating the efficacy and safety of the drug. The primary endpoint of sustained remission and important secondary endpoints of the study were met, AbbVie said.
The company anticipates final approval from the European Commission for the product in the first half of 2025.
Giant cell arteritis is an inflammatory disease that can result in blindness and stroke if left untreated, the company said.
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