Logo

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

Share this

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


Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Related News/Articles

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions