COVID-19: Gilead freezes compassionate access to remdesivir due to “overwhelming demand”, BMS and Lilly delay new study launches
pharmafile | March 24, 2020 | News story | Manufacturing and Production, Medical Communications, Research and Development | Bristol-Myers Squibb, Eli Lilly, Gilead, Roche, cornavirus, pharma
As national governments continue to ramp up measures to contain the ongoing COVID-19 coronavirus outbreak, so too are pharma and biotech organisations in the race to find a working treatment for the disease.
Gilead has emerged at the front of the pack with its antiviral therapy remdesivir, which is currently proceeding through two late-stage clinical trials. But as a result of tentative success the drug has shown, the company has said it is facing “overwhelming demand” of compassionate use requests to receive the treatment.
As a result, the company confirmed it has placed such requests on a temporary hold until it can process the ones it has already received, and it is currently moving to transition from these requests to expanded access programmes in order to “accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients.”
“We are focused now on processing previously approved requests and anticipate the expanded access programmes will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed” the company said in a statement. “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. We recognise the urgent need and are working to implement expanded access programmes as quickly as possible, with the continued support and collaboration of regulatory agencies.”
Gilead has studied remdesivir in a range of infectious diseases including Ebola, MERS and SARS, the latter two of which originate from coronaviruses comparable to the new strain sweeping across the globe. The company has confirmed it is currently working with regulators worldwide to ensure access to the drug as soon as is workable.
Eli Lilly has echoed similar sentiments, announcing that it will be delaying the launch of new studies and freezing enrolment for additional participants for ongoing ones due to the pressure the outbreak is placing on healthcare operations.
With these new measures, the company hopes to “ease the burden on participating healthcare facilities and allow physicians to focus more of their efforts on combatting COVID-19,” according to Chief Medical Officer Tim Garnett.
“For patients already enrolled in clinical trials, discontinuation would disrupt their treatment and potentially diminish the societal value of the research information to which they are contributing,” he added. “We will maintain ongoing studies, but with study-by-study consideration.”
The company announced earlier this month it would be partnering with AbCellera on the development of therapeutic and prophylactic treatments for the novel coronavirus.
Bristol-Myers Squibb took the same stance, also confirming it would not be starting any new trials for at least three weeks, though this timeframe will be reviewed.
Roche, meanwhile, has revealed that it has received FDA approval to go ahead with its Phase 3 trial in partnership with the US Biomedical Advanced Research and Development Authority (BARDA) to investigate the efficacy of intravenous Actemra (tocilizumab) in the treatment of severe COVID-19 pneumonia hospitalisation when combined with standard care in adults. The trial aims to recruit around 330 patients worldwide in early April.
The therapy already boasts approval to treat a number of conditions including moderately to severely active rheumatoid arthritis in adult patients, and active polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, or CAR T cell-induced cytokine release syndrome in patients at least two years old.
Roche previously secured backing from Chinese authorities to trial the drug in the country in novel coronavirus patients.
Matt Fellows
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