Snapshot

The Coronavirus Treatment Acceleration Program (CTAP) pathway has been developed by the US Food and Drug Administration of United States.

This pathway can be used where COVID-19 therapies can either be single agent treatments or combination therapies. Single agent treatments being studied/considered in this pathway are: 1. Antiviral drugs which keep viruses from multiplying and are used to treat many viral infections (such as HIV, Herpes, Hepatitis C, and influenza). 2. 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. 3. 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. 4. Cell therapy products include cellular immunotherapies and other types of both autologous and allogeneic cells, such as stem cells, and related products. 5. 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. According to the US FDA, the diversity of therapeutic approaches being investigated is important because it rapidly expands their understanding of the effect of different categories of potential treatments..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The FDA recognized that there would be a need for early and frequent discussions between the agency and potential therapeutic product developers. So early on, they set up an email inbox for COVID-19 therapeutic development inquiries, COVID19-productdevelopment@fda.hhs.gov. It helps researchers and developers get directed to the right person on the first try and enables the FDA to track inquiries. Each inquiry the FDA receives is reviewed by a triage team that is composed of experienced clinical reviewers, other scientific reviewers, policy experts and regulatory project management staff. The team strives to acknowledge receipt within 24 hours. These staff help those with proposals for potential COVID-19 therapeutics identify and add any information necessary to ensure that the proposal is complete enough for productive discussion. Then, the team sends the proposal with a brief synopsis to the right organizational unit within the FDA for review by disease area experts. Teams of experienced clinical reviewers and regulatory affairs experts in CDER and CBER provide outreach and regulatory advice to less experienced inquirers. Preliminary, partially-formed inquiries go to them before they are assigned to product review teams to determine next steps for engaging with the FDA, including what regulatory submission is appropriate, what to include in that submission, and how to submit it. Once individual inquiries develop into proposals, the FDA's discussions with sponsors can then meet several key milestones: 1. Pre-Investigational New Drug (Pre-IND) Meetings, where sponsors seek initial advice on their proposed development programs. Information about Pre-INDs, including guidance on how to efficiently engage with the FDA and expedite clinical trial initiation, is available at Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency (https://www.fda.gov/drugs/coronavirus-covid-19-drugs/drug-development-inquiries-drugs-address-covid-19-public-health-emergency). 2. INDs, to study therapeutics in humans. More information is available at CDER’s “Investigational New Drug (IND) Application” webpage (https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application). While the FDA is committed to moving products into clinical trials efficiently, they must also work to ensure patients are not exposed to an unreasonable and significant risk of illness or injury. More information is available at “Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19.” (https://www.fda.gov/drugs/coronavirus-covid-19-drugs/ensuring-safety-patients-clinical-trials-studying-investigational-new-drugs-prevent-or-treat-covid) 3. Emergency Use Authorizations (EUAs). Before a therapeutic is approved for use in COVID-19 patients, the FDA can issue an “emergency use authorization” for the product’s emergency use if certain statutory requirements are met, such as when there is no adequate, approved and available alternative therapy and the known and potential benefits of the product for the proposed use outweigh its known and potential risks. This is not a usual step in drug or biologic development, but can be a key step in facilitating patient access. More information is available on the FDA’s Emergency Use Authorization (EUA) webpage (https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs). For most new or repurposed potential therapeutics for COVID-19, pre-IND advice and submission of an IND is the recommended regulatory pathway. 4. New Drug Applications (NDA) and Biologics License Applications (BLA), seeking FDA approval of drugs and biologics for use in COVID-19 patients. NB: While the US FDA has shortened their timelines, their regulatory review and decision-making processes have not changed. Interactions with review teams follow the usual stable, predictable, and flexible process. The US FDA gives all researchers and developers their best advice, apply their legal and regulatory standards, and make decisions on the basis of the science and the data.