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Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

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Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

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  • The NDA filing is based on P-III studies evaluating Veklury vs PBO- conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement
  • Across multiple studies- Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups- with no new safety signals identified
  • Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro/ in vivo in animal models against multiple emerging viral pathogens. The therapy has been approved by multiple regulatory authorities across the globe- including the EU and Japan

­ Ref: Gilead  | Image: Gilead

Click here to­ read the full press release 

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