news

FDA approves remdesivir for treatment of COVID-19

2
SHARES

The FDA has given marketing authorisation for Veklury (remdesivir) to treat COVID-19 patients requiring hospitalisation.

The US Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for use in adult and paediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalisation.

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

The marketing authorisation has been granted to Gilead Sciences. The company says that remdesivir should only be administered in a hospital or a healthcare setting capable of providing acute care comparable to inpatient hospital care. 

The FDA says that this approval does not include the entire population that had been authorised to use remdesivir under an Emergency Use Authorization (EUA). 

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Dr Stephen Hahn. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

The approval of remdesivir was supported by the agency’s analysis of data from three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe COVID-19.

One trial was a randomised, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the US National Institute of Allergy and Infectious Diseases (NIAID), evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The trial looked at 1,062 hospitalised subjects with mild, moderate and severe COVID-19 who received remdesivir or placebo, plus standard of care. 

The second trial was a randomised, open-label multi-centre clinical trial of hospitalised adult subjects with moderate COVID-19. It compared treatment with remdesivir for five days and treatment with remdesivir for 10 days with standard of care. 

A third separate, randomised, open-label multi-centre clinical trial of hospitalised adult subjects with severe COVID-19 compared treatment with remdesivir for five days and treatment with remdesivir for 10 days. 

Share via
Share via