FDA accelerating COVID-19 therapies with CTAP program
The U.S. Food and Drug Administration (FDA) announced it has created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP). The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.
The FDA dashboard provides a snapshot of development of potential COVID-19 therapeutics. Given the urgent nature of the pandemic and the number of companies and researchers developing COVID-19 related therapies, the following numbers may change frequently. FDA will update these numbers monthly. As of September 30, 2020, the snapshot is:
· 550+ drug development programs in planning stages
· 350+ trails reviewed by FDA
· 5 COVID-19 treatments currently authorized for Emergency Use
· 0 treatments approved by FDA for use in COVID-19
The FDA bar chart spans a number of categories, including:
· Antiviral drugs keep viruses from multiplying and are used to treat many viral infections (such as HIV, Herpes, Hepatitis C, and influenza).
· Immunomodulators are aimed at tamping down the body’s own immune reaction to the virus, in cases where the body’s reaction basically goes overboard and starts attacking the patient’s own organs.
· Neutralizing antibody therapies may help individuals fight the virus and include manufactured antibodies, animal-sourced antibody therapies, and blood-derived products such as convalescent plasma and hyperimmune globulin, which contain antibodies taken from people who have previously had COVID-19.
· Cell therapy products include cellular immunotherapies and other types of both autologous and allogeneic cells, such as stem cells, and related products.
· Gene therapy products seek to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.
The diversity of therapeutic approaches being investigated is important because it rapidly expands our understanding of the effect of different categories of potential treatments.
The stages of COVID-19 trials in the U.S. include:
· Ongoing trials fall into two categories: early stage and late stage.
· Early stage trials test safety and sometimes dosing. They rarely provide sufficient evidence to support Emergency Use Authorization or approval.
· Late stage trials assess safety and establish whether the treatment is effective. They may generate sufficient evidence to support the statutory standards for Emergency Use Authorization or approval.
For Researchers and Developers of Therapeutics
FDA is accelerating the development and publication of guidances and other information for industry on developing COVID-19-related treatments. Key references include:
· Information and guidance on how to efficiently engage with FDA and expedite clinical trial initiation may be found at: Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency·
· General advice concerning the development of COVID-19 treatments may be found at: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
· General advice concerning pre-IND meeting request content for COVID-19 treatments is provided at: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products
· Information on expediting quality assessments for products to treat COVID-19 patients and transferring manufacturing to new or alternative sites to avoid supply disruptions may be found at: COVID-19 Manufacturing, Supply Chain, and Drug Inspections
· More information about the availability of COVID-19 treatments under an Emergency Use Authorization may be found at: FDA’s Emergency Use Authorization (EUA)
Contact information for Sponsors
· Sponsors of CDER regulated therapeutics should send COVID-19 product development inquiries to [email protected]
· Sponsors of CBER regulated therapeutics should send COVID-19 product development inquiries to [email protected]. Additional information about CBER-Regulated Therapeutics and CTAP can be found at Coronavirus (COVID-19) | CBER-Regulated Biologics
· Sponsors who are unsure of whether their drug is CDER- or CBER-regulated should make initial contact for COVID-19 drug development by contacting FDA at [email protected]
· Medical devices do not fall within the CTAP program. Device sponsors should contact CDRH directly at [email protected] for in vitro diagnostics (IVDs) and [email protected] for non-IVD medical devices
· As a general matter, if your product is already assigned to CBER or CDRH or you have been in contact with Center review staff regarding your product, submission of additional inquiries or materials to the CTAP mailbox are not necessary and may result in unnecessary delays in processing your information
For Patients and Consumers
· More information on how FDA ensures the safety of patients in COVID-19 clinical trials may be found at: Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19
· Clearly understandable explanations of key technical terms are at: Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19
· Answers to frequently asked questions about therapies for COVID-19 and FDA’s related work can be found at: FDA’s Frequently Asked Questions on COVID-19
· If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma. Information can be found here: Donate COVID-19 Plasma
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Partnership
Another critical initiative is the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, coordinated by the Foundation for the National Institutes of Health (FNIH). ACTIV involves a collaboration among government and industry partners, including FDA, to prioritize vaccine and therapeutic candidates, streamline clinical trials, and rapidly expand the clinical research resources focused on developing therapies for the COVID-19 pandemic. Among other things, ACTIV government and industry partners provide subject matter expertise and/or funding to identify, prioritize and facilitate the entry of some of the most promising candidates into clinical trials.
CTAP plays an important role in these efforts by providing FDA subject matter expertise for ACTIV initiatives, including for clinical trial design and conduct and relevant FDA regulatory standards for therapeutics. Under the CTAP program, FDA can better ensure that critical focus is placed on reviewing those therapies prioritized by the ACTIV partnership. The involvement of FDA in the ACTIV partnership will also help ensure these reviews are more efficient, particularly in evaluating proposed pre-clinical and clinical studies that received ACTIV input. This more comprehensive and cooperative approach involving key partners can help ensure that safe and effective therapies for COVID are available more quickly for patients. However, it should be noted that FDA’s regulatory functions are distinct from its contribution of technical advice to other US government programs. The FDA will evaluate each product submitted for authorization or approval based on the applicable legal and regulatory requirements and on the bases of the best available scientific and clinical evidence.
