Gilead Sciences’ antiviral drug remdesivir has received approval from the U.S. Food and Drug Administration as a treatment for COVID-19, according to a letter from the company’s chief medical officer.
The drug is sold under the brand name Veklury and is the first antiviral treatment “proven to help patients hospitalized with COVID-19 recover more quickly,” Dr. Merdad Parsey, CMO of Gilead Sciences said.
The first patient with COVID-19 received Veklury in January of this year through emergency use protocols, Parsey wrote in the letter.
Based on clinical trial results, the FDA approved remdesivir for adults and adolescents (at least 12 years of age and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.
The FDA had this to say on the drug’s approval:
On October 22, 2020, FDA approved NDA 214787 for Veklury (remdesivir), which is indicated for adults and pediatric patients (12 years and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Under its approval, Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Having concluded that revising this EUA is appropriate to protect the public health or safety under Section 564(g)(2) of the Act, FDA is reissuing the October 16, 2020, letter in its entirety with revisions to remove uses previously authorized that are now the subject of the approved NDA 214787 for Veklury, and to continue authorizing Veklury for emergency use to treat suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.U.S. Food and Drug Administration
Read the entire letter from Parsey here.
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