RAHWAY, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today the U.S. Food and Drug Administration (FDA) approval of NUMELVI™ (atinvicitinib tablets) – the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs six months of age and older. The product is expected to b. ...

Core Insights - AbbVie announced that the European Commission granted marketing authorization for RINVOQ® (upadacitinib) for the treatment of giant cell arteritis (GCA) in adult patients, making it the first and only oral JAK inhibitor approved in the EU for this condition [1][4]. Group 1: Product Approval and Significance - The approval of RINVOQ provides a new treatment option for patients with GCA, a condition that primarily affects older adults and can lead to severe complications such as vision loss [2][4]. - RINVOQ's approval is based on the results from the Phase 3 SELECT-GCA trial, which demonstrated significant efficacy in achieving sustained remission and reducing steroid exposure compared to placebo [4][8]. Group 2: Clinical Trial Results - In the SELECT-GCA trial, 46.4% of patients receiving RINVOQ achieved sustained remission at week 52, compared to 29.0% in the placebo group (p=0.002) [5][8]. - Key secondary endpoints showed that 34.3% of patients on RINVOQ experienced at least one disease flare, compared to 55.6% in the placebo group (p=0.001), and cumulative steroid exposure was significantly lower in the RINVOQ group (median exposure of 1615 mg vs. 2882 mg, p<0.001) [5][6]. Group 3: Safety Profile - The safety profile of RINVOQ in the trial was consistent with other approved indications, with serious infections occurring in 5.7% of the RINVOQ group compared to 10.7% in the placebo group [3][40]. - No major adverse cardiac events were reported in the RINVOQ group, while two events occurred in the placebo group [6][40]. Group 4: Broader Context of RINVOQ - RINVOQ is already approved for multiple indications in the EU, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, marking the eighth approved indication for the drug [4][10]. - The drug is a selective and reversible JAK inhibitor, which is being studied for various immune-mediated inflammatory diseases [9][10].