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Gilead’s remdesivir use for COVID-19 could spill over beyond ideal patient groups, possibly straining supply, says GlobalData

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

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.”

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