Latest Breaking News On - Krems - Page 2 : comparemela.com

While the U.S. FDA didn’t ask for more study data or have safety or efficacy concerns, it does want modifications to Alexion, Astrazeneca Rare Disease’s sBLA for Ultomiris (ravulizumab-cwvz) to treat adults with the rare central nervous system disease neuromyelitis optica spectrum disorder. The agency has issued a complete response letter (CRL) requesting changes to Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) to better validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics before being treated.

Astrazeneca rare diseaseUltomiri risk evaluationMitigation strategyAstrazeneca plcAstrazeneca rare diseaseNeuromyelitis optica spectrum disorderComplete response letterRare diseaseAlexion pharmaceuticals inc