The Food and Drug Administration hopes to expedite development of treatments for Covid-19 under a new program that the agency announced Tuesday.
The FDA said that under the Coronavirus Treatment Acceleration Program, or CTAP, it is redeploying staff and streamlining processes with the goal of speeding up reviews of clinical trial protocols and single-patient expanded-access requests.
“Our staff continues to work across all sectors to expedite the development of numerous innovative potential prevention and treatment approaches,” FDA Commissioner Stephen Hahn said in a statement. “We are also looking at pragmatic and expedited ways to make these products available to patients while still ensuring the FDA’s standards are met.”
The agency said it is organizing requests from developers and scientists seeking to develop new drugs to treat Covid-19, the disease caused by the SARS-CoV-2 virus, according to their urgency, helping relevant FDA staff in touch with them and providing input to expedite the initiation of studies. It said that in doing so, it has managed to review some clinical trial protocols within 24 hours and reviewed expanded-access requests generally within three hours. It has also created protocols that can be used across institutions and platforms.
To accomplish this, the FDA said it has redeployed medical and regulatory staff to serve on teams dedicated to reviewing Covid-19 therapies and streamlined the ways that requests and inquiries can be submitted to the agency.
Drugs currently in clinical development for Covid-19 include Gilead Sciences’ remdesivir, Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab), and the antimalarial drugs hydroxychloroquine and chloroquine. The latter two drugs also received an emergency use authorization from the FDA, particularly for patients who are unable to take part in the ongoing clinical trials.
Some clinical trials of Covid-19 therapies and vaccines have gotten up and running very quickly, such as Moderna’s Phase I study of the vaccine mRNA-1273 and the Regeneron-Sanofi trial.
The agency had previously wound down some operations due to the pandemic, including suspending on-site foreign inspections and also some advisory committee meetings.
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