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FDA Launches Program to Speed Development of COVID-19 Treatments

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FDA Launches Program to Speed Development of COVID-19 Treatments

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FDA Launches Program to Speed Development of COVID-19 Treatments

Press Release
The FDA unveiled a new initiative, dubbed the ?Coronavirus Treatment Acceleration Programme (CTAP),? designed to expedite the development of effective treatments for patients with COVID-19. Alex Azar, secretary of the US Department of Health and Human Services, said that ?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.? According to the FDA, CTAP is using ?every tool? at the agency?s disposal to bring new therapies to patients as quickly as possible. These include triaging requests from developers and scientists working on new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies under way quickly. The agency noted, for example, that it ?has reviewed study protocols within 24 hours in many cases and has reviewed single-patient expanded access requests generally within three hours.? It said it has also rearranged medical and regulatory staff to serve on review teams dedicated specifically to COVID-19 therapies and provided resources to help researchers submit emergency requests to use investigational products. In addition, the agency highlighted the potential of real-world data sources to complement traditional clinical studies, and as such, it is ?advancing relationships with partners in the public and private sectors to rapidly collect and analyse information in areas such as illness patterns and treatment outcomes.? Potential treatments currently being investigated for COVID-19 include antivirals such as Gilead Sciences? remdesivir, while scientists are also evaluating other drugs, such as IL-6 receptor inhibitors, which include Roche?s Actemra (tocilizumab) and Sanofi and Regeneron Pharmaceuticals? Kevzara (sarilumab), that may help reduce lung inflammation and improve lung function in infected patients. The agency also pointed to interest in examining the potential of antibody-rich blood products such as convalescent plasma and hyperimmune globulin taken from blood donated by recovered patients. Meanwhile, it said work is ongoing to evaluate whether existing therapies such as the anitmalarials chloroquine and hydroxychloroquine, with or without other medications, can help treat patients with COVID-19. The FDA recently issued an emergency-use authorization to allow donated hydroxychloroquine and chloroquine to be used amid the pandemic.

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