Gilead Sciences said it is temporarily halting new individual compassionate-use requests for remdesivir, which is undergoing multiple clinical trials as a potential treatment for COVID-19, citing "overwhelming demand over the last several days." The company noted that it is working to streamline the emergency access process for the experimental broad-spectrum antiviral and is currently transitioning from individual compassionate-use requests to expanded access programmes.
"We recognise that there are severely ill patients who are unable to enroll in clinical trials and for whom no approved treatment options are effective," Gilead stated, adding that it is "working to implement expanded access programmes as quickly as possible, with the continued support and collaboration of regulatory agencies." The drugmaker indicated that as an exception, compassionate-use requests may still be made for pregnant women and children under 18 with confirmed COVID-19 and severe manifestations of disease.
Remdesivir is being evaluated as a potential treatment for patients with COVID-19 in several trials, including in the US and China. Gilead explained that it has been working with regulatory agencies to provide remdesivir to severely ill patients who are not enrolled in studies, noting that it has so far provided emergency access to the drug for several hundred patients in the US, Europe and Japan.
However, as a result of the outbreak spreading in Europe and the US, Gilead says there has been an "exponential increase" in compassionate-use requests that has "flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic." The company indicated that the shift toward expanded access programmes will start in a similar timeframe that new requests for compassionate use would have been processed. In the meantime, it is now focused on processing previously approved compassionate-use requests.
"Enrollment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of this investigational medicine," the company added.
Last week, Bayer, Novartis and Teva said they would donate the antimalarial drugs chloroquine and hydroxychloroquine as part of global efforts exploring their use to treat patients with COVID-19 infection. However, several US state pharmacy boards recently took steps to limit prescriptions of the drugs which are in short supply as demand surges.
For related analysis, see ViewPoints: Initial glimmers of hope for COVID-19 therapeutics.
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