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FDA approves Gilead's Remdesivir for patients with high risk for developing severe COVID

DTMT Network

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted expedited approval of a supplemental new drug application for its remdesivir marketed under the brand name, Veklury for the treatment of non-hospitalised adult and adolescent patients who are at high risk of progression to severe COVID19, including hospitalisation or death.

“This approval expands the role of Veklury, which is the antiviral standard of care for the treatment of patients hospitalised with COVID19,” the announcement stated.

“The expanded indication allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days,” it added.

The company informed that the  FDA has also expanded the paediatric Emergency Use Authorisation (EUA) of Veklury to include non-hospitalised paediatric patients younger than 12 years of age who are at high risk of disease progression.

“Remdesivir has now helped to treat more than 10 million people around the world with COVID19 and continues to play a key role in helping to reduce the burden of the pandemic,” Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences said.

“Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID19 infection, in addition to helping patients who are hospitalized with the disease,” he added.

“While we continue to advance remdesivir to benefit more patients in multiple settings, we are also advancing our investigational oral compounds. These are based on the same antiviral mechanism of action as remdesivir and a Phase 1 trial for our oral COVID19 antiviral, GS-5245 is now underway,” he further added.


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