FDA issues two guidances to accelerate Covid-19 treatments
The FDA on Monday evening issued two guidances intended to accelerate the development of products to treat or prevent coronavirus disease (Covid-19), laying out recommendations to help companies get to the investigational new drug application (IND) stage and clinical trial design considerations for later-stage studies.
“Accelerating the investigation of safe and effective therapies that could benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We are committed to maximizing our regulatory flexibility and using every tool at our disposal to speed the development and availability of these medical products and believe these new guidances will help innovators and researchers do just that,” said FDA Commissioner Stephen Hahn.
The new guidance follows the launch of FDA’s coronavirus treatment acceleration program (CTAP) in March and the National Institutes of Health’s (NIH) Accelerating Covid-19 Therapeutic Innovations and Vaccines (ACTIV) public-private partnership in April.
As of Monday, FDA said there are 144 active clinical trials of therapeutics for Covid-19 and that it is aware of more than 450 development programs that are still in planning stages.
The first of the two guidances focuses on walking drugmakers through the pre-IND process to provide them with feedback and help them get their products into clinical trials in a quick and efficient manner.
“To facilitate this, we are urging sponsors to submit a pre-IND meeting request that allows early and thorough review and discussion between the sponsor and FDA, which can lead to more rapid review of subsequent IND and assurance of subject safety,” FDA writes, noting it has assembled a multispecialty, multidisciplinary team within the Center for Drug Evaluation and Research for reviewing drug development proposals for Covid-19.
FDA explains that during the Covid-19 public health emergency, it is consolidating its pre-IND meeting request and package development process “into a single step.”
In most cases, FDA says it will review and respond to pre-IND meeting requests in writing only and that requests will be prioritized based on “completeness of the submission and scientific merit.”
FDA also says that sponsors with active INDs for drugs currently in development or those that have submitted pre-IND meeting requests or INDs to FDA to repurpose an already-approved drug for Covid-19 should submit a new pre-IND meeting request cross-referencing any existing applications for the product instead of amending an existing submission.
Additionally, FDA explains that sponsors should begin discussions about investigational products for Covid-19 through pre-IND meeting requests as opposed to pre-emergency use authorization (pre-EUA) requests.
“While we are encouraged to see the rapid development of potential therapies for COVID-19, in most cases the effectiveness of novel or repurposed therapies is unknown at the pre-IND stage. Authorization of drugs through the EUA mechanism involves an understanding that the known and potential benefits outweigh the known and potential risks of the drug for the diagnosis, treatment, or prevention of an appropriate disease or condition. In general, drugs being studied for treatment or prevention of COVID-19 have insufficient data for FDA to make such a determination,” FDA writes.
The guidance goes on to provide specific recommendations for the content of pre-IND meeting request submissions; nonclinical, clinical and quality considerations; and additional recommendations for antiviral and inhalation drugs.
In the second guidance, FDA provides recommendations for clinical trial design for Phase 2 and 3 clinical trials intended to establish safety and efficacy for therapeutic or prophylactic drugs and biologics for Covid-19.
FDA says the guidance is focused on the development of direct antiviral drugs or products with immunomodulatory activity and notes that the guidance does not apply to preventative vaccines or convalescent plasma.
“FDA anticipates this guidance will help sponsors to efficiently design studies that may lead to the review and potential approval of safe and effective drugs and biological products to address the COVID-19 pandemic,” FDA writes.
Specifically, the guidance provides recommendations for study population, trial design, efficacy endpoints, safety and statistical considerations.
FDA says it “strongly recommends that drugs to treat or prevent COVID-19 be evaluated in randomized, placebo-controlled, double-blind clinical trials using a superiority design,” and that standard of care should be applied in all treatment arms.
“Sponsors should address anticipated off-label use of any other drugs, devices, or interventions that might be used to manage COVID-19,” FDA writes.
FDA opens the door to decentralized or platform clinical trials and requests that sponsors considering such studies contact the agency.
FDA also provides a list of what it considers to be important clinical outcome measures for treatment trials, including all-cause mortality, respiratory failure, need for invasive mechanical ventilation and sustained clinical recovery. For prevention trials, FDA says the primary endpoint should be the occurrence of laboratory-confirmed SARS-CoV-2 infection or SARS-CoV-2 infection with symptoms within a prespecified timeframe.
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