EU Gives Conditional Market Authorization For Gilead's Remdesivir Treat COVID-19

Gilead Sciences Inc. (GILD) said Friday that the European Commission has granted conditional marketing authorization for Veklury or remdesivir as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19.

As per the authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents, with pneumonia requiring supplemental oxygen.

The company noted that the conditional marketing authorization for Veklury is supported by the U.S. National Institute of Allergy and Infectious Diseases' global Phase 3 trial of remdesivir.

A conditional marketing authorization in Europe is initially valid for one year but can be extended or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data.

Remdesivir has been approved as a treatment for patients with severe COVID-19 in Japan, Taiwan, India, Singapore, the United Arab Emirates and the European Union. Outside of these regions, remdesivir is an investigational, unapproved drug, the company said.

Last month, Gilead Sciences said it decided to price remdesivir at $390 per vial for governments of developed countries. In the U.S. also, the same government price of $390 per vial will apply.

Based on current treatment patterns, the vast majority of patients are anticipated to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient.

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