Genentech Receives the US FDA’s Approval for P-III Clinical Study Evaluating Actemra to Treat Hospitalized Patients with Severe COVID-19 Pneumonia

 Genentech Receives the US FDA’s Approval for P-III Clinical Study Evaluating Actemra to Treat Hospitalized Patients with Severe COVID-19 Pneumonia

Roche Receives the US FDA’s Approval for P-III Clinical Study Evaluating Actemra to Treat Hospitalized Patients with Severe COVID-19 Pneumonia

Shots:

  • The US FDA has approved the P-III clinical study assessing Actemra (tocilizumab, IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 pneumonia with its 1EPs & 2EPs as clinical status, mortality, mechanical ventilation and ICU variables
  • Post randomization, patients will be followed for 60 days and analysis will be conducted to look for early evidence of efficacy. Additionally, Genentech will donate 10,000 vials of Actemra to the US Strategic National Stockpile for future use at the direction of the US HHS
  • The current US supply of Actemra for approved indications is not expected to be impacted as Genentech is working with distributors to manage drug supply targeting the medical needs of the patients

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

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

Related post