AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
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In its complete response letter, the regulator asked AstraZeneca to improve Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) and include a background check for patients’ meningococcal vaccination status or require prophylactic antibiotic use before treatment.
And then there were two. Janssen (Johnson & Johnson) is no longer in the running to acquire rare disease player Horizon Therapeutics, the company announced Saturday.