Gilead Announces Transition from Individual Compassionate Use to Expanded Access Programs for Remdesivir Amid Surging Demand
Gilead Sciences
Antiviral Drug Developer
From Jike Pharmaceutical News
On March 23, Gilead announced that it is currently transitioning from providing individual compassionate use emergency access to expanded access programs. This approach will accelerate critically ill patients’ access to remdesivir and enable the collection of data on all participating patients. These programs are being rapidly developed in collaboration with regulatory and health authorities worldwide, including the FDA, CDC, DHHS, NIAID, DoD, Chinese CDC, NMPA, and WHO.
As of press time, Gilead Sciences has initiated six clinical trial programs globally. Enrollment in these clinical trials is the primary means of accessing Remdesivir to generate critical data regarding the appropriate use of this investigational drug. Requests for emergency treatment are considered only when enrollment in a clinical trial is not a feasible option.
Gilead stated that requests for compassionate use have “grown exponentially” in recent weeks due to the spread of the coronavirus in Europe and the United States, which has “overwhelmed” its treatment access system. This system was established to provide very limited access to the medication and was never intended to respond to a pandemic. “Given the overwhelming demand over the past few days, we are unable to accept new individual compassionate use requests during this transition period, with the exception of requests for pregnant women and children under 18 years of age who have confirmed COVID-19 and exhibit severe associated symptoms. Our current focus is on processing previously approved applications, and we anticipate that expanded access programs will be launched within a similar expected timeframe for handling any new compassionate use applications.”
Notably, on March 13, the White House stated that remdesivir is a highly promising therapeutic agent. Previously, the New England Journal of Medicine (NEJM) published online several articles on cases of the novel coronavirus (2019-nCoV), one of which described the diagnosis, treatment, and clinical manifestations of the first confirmed case in the United States, noting that “the patient’s clinical symptoms showed immediate improvement after one night of treatment.”
References:
[1] Emergency Access to Remdesivir Outside of Clinical Trials. Retrieved 2020-03-23, from https://www.gilead.com/purpose/advancing-global-health/covid-19/emergency-access-to-remdesivir-outside-of-clinical-trials
Original Title: Official Announcement | Gilead’s Statement on Emergency Access to Remdesivir Outside of Clinical Trials
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