FDA Announces Accelerated Program for Potential COVID-19 Therapies

The FDA has announced that it is accelerating the development of potentially safe and effective life-saving treatments for patients with the novel coronavirus (COVID-19).

The public-private program, known as Coronavirus Treatment Acceleration Program (CTAP), is using tools available to the agency to bring new therapies to patients with COVID-19 as quickly as possible, while supporting research to further evaluate whether these medical countermeasures are safe and effective as treatment.

“As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of HHS to support potential coronavirus treatments for weeks now. Each day, President Trump’s all-of-America approach is making progress and providing new hope in our fight against the coronavirus,” said Alex Azar, secretary of Health and Human Services, in a prepared statement.

There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA’s accelerator program, staff from the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance, and technical assistance as quickly as possible.

As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, communicating with relevant FDA staff, and providing rapid, interactive input to quickly commence studies, such as reviewing study protocols and single-patient expanded access requests. The FDA is also collaborating with federal partners, developers, and researchers to create protocols that can be used across institutions and programs to streamline efforts, according to the agency’s press release.

“Accelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We want to help patients by expediting promising treatments, and are committed to maximizing our regulatory flexibility, and proactively bringing the best innovators together to ensure we are getting the right treatments to the right patients at the right time,” said Stephen M. Hahn, commissioner of the FDA.

The FDA has redeployed medical and regulatory staff to serve on COVID-19 therapy-dedicated review teams, streamlined processes, and operations for developers and scientists to send inquires and requests, and provided resources to health care providers and researchers to aid in submitting emergency requests to use investigational products.

Therapeutic areas that are currently being evaluated include antiviral drugs, such as remdesivir (Gilead Sciences, Inc) that may treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may reduce lung inflammation and improve the lung function for patients with COVID-19. There is additional interest in examining whether therapies such as convalescent plasma and hyperimmune globulin, antibody-rich blood products taken from donated blood from patients who have recovered from the virus, could shorten the length or lessen the severity of the disease. Work is also ongoing to evaluate whether existing therapies such as chloroquine and hydroxychloroquine alone or as an adjuvant therapy may help patients with COVID-19.

The announcement mentioned the potential for real-world data sources that may complement traditional clinical studies, thereby speeding the process of evaluating the impact of potential COVID-19 therapies. The agency is currently advancing relationships with partners in the public and private sectors to rapidly collect and analyze information in areas such as illness patterns and treatment outcomes.

“The FDA is focused on facilitating the development of COVID-19 therapies in order to expedite the development of data on these medical countermeasures to attain full FDA approval, which relies on data from adequate and well-controlled trails to determine if an experimental treatment can safely and effectively benefit patients,” the statement noted. “The agency will outline additional information in the near future to provide a greater understanding of the full breadth of work in this area, to the extent permitted by confidentiality laws.”

REFERENCE

Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 [news release]. FDA website. Published March 31, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19. Accessed March 31, 2020.