Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

 Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

Shots:

  • The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
  • ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
  • Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the first and only approved COVID-19 treatment in the United States.

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Los Angeles Times

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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