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Alexion to Initiate P-III Study of Ultomiris (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19

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Alexion to Initiate P-III Study of Ultomiris (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19

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  • The P-III study will evaluate Ultomiris vs BSC in 270 patients in a ratio (2:1) hospitalized with COVID-19 and severe pneumonia- acute lung injury or ARDS. In the study- patients will receive a weight-based loading dose of the therapy @day 1 (2400mg for 40-60kg- 2700mg for 60-100kg- or 3000mg for ≥100kg) with a follow-up dosing @Days 5- 10 & 15- patients weighing 40-60kg will receive 600mg and ≥60kg will receive 900mg
  • The 1EP is survival @day 29 and the 2EPs involve mechanical ventilation- oxygenation- duration of ICU stays and hospitalization- and safety. The study follows the US FDA’s rapid review and acceptance of Ultomiris’ IND for severe COVID-19
  • The company expects the initiation of enrollment in May. Additionally- Alexion has initiated emergency EAP in the US and France for SOLIRIS in patients with severe COVID-19 pneumonia

Click here ­to­ read full press release/ article | Ref: Alexion  | Image:  WSJ


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