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

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

Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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