Of possible interest: Remdesivir Changes Access Outside of Clinical Trials

On March 22, 2020, Gilead Sciences announced they are transitioning from Individual Compassionate Use requests for remdesivir to Expanded Access Programs. This change should enable accelerated access to remdesivir for severely ill coronavirus patients. 

These US Food and Drug Administration (FDA) programs are currently under rapid development in conjunction with national regulatory authorities.

Throughout this program transition period, Gilead is unable to accept new individual compassionate use requests due to overwhelming demand.

As an exception, compassionate use requests for remdesivir may still be made for pregnant women and children less than 18 years of age, with confirmed COVID-19disease, and severe manifestations of the disease.

Gilead is working to rapidly assess the safety and efficacy of remdesivir as a potential treatment for COVID-19 through multiple ongoing clinical trials. 

Clinical trials are the primary way to generate critical data that informs the appropriate use of investigational medicines.

On February 25, 2020, a randomized, controlled clinical trial to evaluate the safety and efficacy of remdesivir in hospitalized adults diagnosed with COVID-19 began at the University of Nebraska Medical Center (UNMC) in Omaha. 

This is the first clinical trial in the USA to evaluate an experimental treatment for COVID-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China.

This disease is caused by the novel SARS-CoV-2 coronavirus.  

Gilead’s statement says ‘We recognize that there are severely ill patients who are unable to enroll in clinical trials and for whom no approved treatment options are effective.’ 

‘Gilead has been working with regulatory agencies to provide remdesivir to these patients where feasible.’ 

‘To date, we have provided emergency access to remdesivir for several hundred patients in the United States, Europe, and Japan.’

‘In recent weeks, there has been an exponential increase in compassionate use requests for emergency access to remdesivir, related to the spread of the coronavirus in Europe and the United States.’

‘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.’

‘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.’

‘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.’

Remdesivir (GS-5734) is a novel antiviral drug in the class of nucleotide analogs. It was developed by Gilead Sciences and has been found to show antiviral activity against other single-stranded RNA viruses such as respiratory syncytial virus, Junin virus, Lassa fever virus, Nipah virus, Hendra virus, and the coronaviruses.

SARS-CoV-2 outbreak news is published by Coronavirus Today.

COVID-19 disease medication development news is published by Precision Vaccinations.