COVID-19 Update: FDA Announces Advisory Committee Meeting to Discuss Moderna’s Vaccine Request for Emergency Use Authorization
Briefing Document fda.gov/media/144434/d…
First FDA Approval for COVID-19: Veklury (remdesivir), an antiviral drug, manufactured by Gilead. It is for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.
The FDA granted Gilead’s application Fast Track and Priority Review designations. Further FDA granted this application a Material Threat Medical Countermeasure Priority Review Voucher. This means additional incentives because COVID-19 falls within this category; that is, medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats. It is important to mention that this approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) (issued on May 1, 2020).
NOTE—FDA had granted Gilead Sciences Orphan Drug status for remdesivir and orphan designation for the “Treatment of coronavirus disease 2019 (COVID-19)” (March 23, 2020) which means tax advantages and exclusivity; however, in an unusual twist, Gilead requested on March 25, 2020 that FDA rescind orphan drug designation.
#COVID_19 Immunity and Compensation under PREP Act Fed. Reg. notice March 17 retroactive effective date Feb. 4, 2020 through Oct. 1, 2024. https://federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures