In order to continue to provide patients with access to the potential treatment, Gilead said it is in the process of transitioning from individual compassionate use requests to expanded access programs.
Michael Vi / Shutterstock
Gilead Sciences has been overwhelmed with requests for remdesivir to treat cases of COVID-19, the disease caused by the novel coronavirus. As a result of that increased demand, the company has been forced to put compassionate use requests on a temporary hold until it can process previously approved requests.
The company made its announcement Sunday. In order to continue to provide patients with access to the potential treatment, Gilead said it is in the process of transitioning from individual compassionate use requests to expanded access programs. Doing so will “both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” Gilead said. During this transition period, Gilead said it is unable to accept new individual compassionate use requests due to an overwhelming demand over the last several days.
“We are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed. As an exception, compassionate use requests may still be made for pregnant women and children less than 18 years of age with confirmed COVID-19 and severe manifestations of disease,” Gilead said. “We recognize the urgent need and are working to implement expanded access programs as quickly as possible, with the continued support and collaboration of regulatory agencies.”
The California-based company said it is attempting to rapidly assess the safety and efficacy of remdesivir as a potential treatment for COVID-19 through multiple ongoing clinical trials. Remdesivir is an antiviral drug that is currently in two late-stage trials for the treatment of COVID-19. The medication has been studied as a potential treatment for Ebola, Marburg, MERS and SARS. MERS and SARS are both caused by coronaviruses that have at least some similarities to the coronavirus causing COVID-19.
Even as the company has been operating the trials in order to generate the critical data that will support use of this medicine for the pandemic, the company said it has been inundated with requests for emergency use of the drug for coronavirus cases. The company said it has been working with regulatory agencies across the globe to provide remdesivir to COVID-19 patients when it is feasible. The company said it has provided the medication to hundreds of patients in the United States, Europe and Japan.
But, as word has gotten out about the potential efficacy of remdesivir in COVID-19, the company said there has “been an exponential increase in compassionate use requests for emergency access to remdesivir” related to the rapid spreading of the coronavirus. The drug has been touted by many medical professionals, as well as President Trump, for the reports of efficacy the drug has shown in the coronavirus pandemic.
“This 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 said in a statement.
There are currently no approved treatments for COVID-19, but a number of companies are working on treatments and vaccines. Companies such as Moderna, BioNTech and CureVac, are attempting to develop a vaccine for COVID-19. Japanese drugmaker Takeda Pharmaceutical is attempting to develop a drug based on the blood of patients who recovered from COVID-19.
