Remdesivir, the only antiviral drug authorized to treat COVID-19, could soon become much more accessible. On Monday, Gilead Sciences (NASDAQ: VALID) completed a submission of a new medication application (NDA) to the FDA that could lead to full approval of the broad-spectrum antiviral, to be marked as a treatment for COVID-19 under the brand name Veklury.
At present, Veklury is available under an emergency use authorization (EUA) which disappears once the circumstances justifying it no longer exist. In addition to providing the company with some clarity about Veklury’s future, a normal FDA approval will allow the company to actually market the drug and gain more control over its distribution.
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Under its EUA, Veklury can only be administered to patients with severe COVID-19, but it is unlikely that full approval will significantly boost sales in the larger population of patients with milder cases. Veklury should be administered via an intravenous infusion over a five-day treatment regimen.
The NDA is supported by two one-arm phase 3 tears that have told us very little. If the FDA hits a sticking point over Veklury, then there will be a lack of a mortality benefit observed during the only randomized, placebo-controlled study supporting the application, a phase 3 trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID).
During the NIAID study, a majority of patients treated in hospital returned with Veklury after 11 days, compared with 15 days among those receiving placebo. The reduction in recovery time is not an insignificant advantage, but given that it does not throw up a measurable reduction in mortality, Veklury does not set a high bar for incoming antiviral treatments to be scrapped.
NIAID is currently treating patients with LY-CoV555 from Eli Lilly (NYSE: LLY) in a multi-agent head-to-head study that seeks to discover which among several experimental COVID-19 treatments works best.
