With the EMA announcing today that it will start a rolling review of Gilead Sciences’ remdesivir for COVID-19 and wide expectations that US Emergency Use Authorization (EUA) will be locked in, reporting from Reynald Castañeda, Pharma Writer for the Investigative News team at GlobalData, a leading data and analytics company, notes that broad use beyond remdesivir’s ideal patients is plausible but could strain supply.

Castañeda notes: “Use in patients on invasive ventilation, or even those with milder symptoms but at risk of progressing, could negatively impact the supply and demand equilibrium for the drug.”

Excitement for remdesivir was at its fever pitch on 29th April when data of varying detail from three different trials were released. The Phase III trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) – considered to be critical for FDA support – reported preliminary positive results. Gilead also announced data from its Phase III trial, while the Lancet published data from the China-based Phase III trial. Today, the EMA announced it would start a rolling review based on NIAID’s results.

Castañeda comments: “All three studies recruited severe patients but with varying definitions, and the NIAID is yet to reveal granular patient profile information from its study. While data so far suggests remdesivir is ideal to use soon after hospitalisations and prior to invasive ventilation, utility is likely to be broader.

Castañeda adds: “Interviewed physicians noted that the balancing act between the drug’s risk-benefit and its supply is critical. Some added Gilead’s data showing remdesivir’s five-day dosing being comparable to the ten-day schedule could open up use outside of the hospital for the shorter course, while the longer course may be for more severe patients detected to have higher viral load.”

Gilead has stated, as of late March, it has increased its supply to more than 30,000 patient courses, assuming a ten-day course. It aims for 140,000 treatment courses by end of May and one million by December.

Castañeda reports: “While physicians agree there is an ideal therapeutic window, they noted there is risk of patients being hospitalised too late, which would diminish remdesivir’s efficacy potential. Nonetheless, remdesivir’s potential for EUA is supported by available data so far, but some noted that the NIAID data only supports symptom relief for the intravenous therapy, with mortality data less convincing. Yet, they noted, the eight-point primary endpoint ordinal scale of time to recovery does have the advantage of offering quicker results—critical in a pandemic—and captures nuances on how patients progress through the disease.”