- The FDA approved Regeneron Pharmaceuticals Inc's and Sanofi SA's Kevzara (sarilumab) for polymyalgia rheumatica (PMR), an inflammatory rheumatic disease,
- The approval covers adult patients who have had an inadequate response to corticosteroids or cannot tolerate corticosteroid taper.
- Kevzara is now approved to treat two chronic inflammatory disorders.
- PMR often initially presents with pain and stiffness around the neck, shoulder, and hip area, and symptoms include fatigue, low-grade fever, and weight loss.
- PMR generally affects people who are 50 years and older.
- The FDA approval for this additional indication for Kevzara is based on results from the SAPHYR Phase 3 trial in patients with steroid-resistant active PMR.
- At 52 weeks, the trial met its primary endpoint, with 28% of Kevzara-treated patients achieving sustained remission compared to 10% for placebo.
- In addition, an analysis of a secondary endpoint showed that the median cumulative CS dose was 777 mg for Kevzara, compared to 2044 mg for the placebo.
- IVERIC bio Inc announced an exploratory time-to-event analysis from the avacincaptad pegol (ACP) GATHER clinical trial program evaluating the reduction in vision loss with ACP 2 mg versus sham treatment.
- The posthoc analysis for vision loss from these pivotal studies signals up to a 59% reduction in the rate of vision loss with ACP 2 mg compared to sham treatment at 12 months.
- Results were consistent in the GATHER1 and GATHER2 clinical trials independently, signaling a 44% reduction and a 59% reduction, respectively, in the rate of vision loss with ACP 2 mg compared to sham over the first 12 months of treatment.
- In a combined analysis of GATHER1 and GATHER2, patients treated with ACP 2 mg experienced a 56% reduction in the rate of vision loss compared to sham over the first 12 months of treatment.
- Avacincaptad pegol (ACP) is under FDA evaluation for safety and efficacy, with a PDUFA Goal Date of August 19, 2023.
- The company plans to submit marketing authorization applications to the European Medicines Agency and the U.K. Medicines and Healthcare Regulatory Agency in 2023, subject to feedback from planned interactions with regulatory authorities in Europe, which is expected in 1H of 2023.
