Gilead Sciences, Inc GILD announced Monday it was seeking complete Food and Drug Administration approval for its drug Remdesivir, which is being used in the treatment of COVID-19.
The drugmaker said it has filed a New Drug Application with the FDA on the basis of two randomized, open-label, multi-center Phase 3 clinical studies conducted by itself, and one other study by Anthony Fauci-led National Institute of Allergy and Infectious Diseases.
The company claims the drug led to faster recovery from COVID-19 compared to placebo, and a 5-to-10-day treatment led to clinical improvements. Gilead noted that the drug was well-tolerated with no “new safety signals identified.”
“Today’s filing is an important milestone as we continue to partner with the U.S. government and healthcare authorities around the globe to address the treatment needs of patients with COVID-19,” Gilead Chief Medical Officer Merdad Parsey said.
Why It Matters
Remdesivir has received regulatory approvals in the European Union and Japan, according to Gilead. The drug is approved for emergency use in COVID-19 patients in the United States by the FDA.
In July, the drugmaker provided additional data on the efficacy of Remdesivir, which associated the drug with an improvement in clinical recovery, and a 62% reduction in risk of mortality compared with standard of care.
Pfizer Inc PFE announced a multiyear agreement with Gilead this month to manufacture and supply Remdesivir, in order to combat the coronavirus crisis.
Raymond James analyst Steven Seedhouse expressed a lack of confidence in Remdesivir, citing 2020 revenue guidance, which is upwards of $3 billion, and is predicated on the company selling 1 to 1.5 million courses at $2500 per course. The analyst said the company is uniquely tied to COVID-19.
Gilead shares closed nearly 1.2% lower at $68.51 on Monday.
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