The goal of the program will be to quickly bring effective medical countermeasures to patients while also supporting research to assess the safety and efficacy of these therapies.
The US Food and Drug Administration (FDA) has
The goal of the program will be to quickly bring effective medical countermeasures to patients while also supporting research to assess the safety and efficacy of these therapies.
“Accelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities,” Stephen M. Hahn, MD, commissioner of the FDA said in the statement. “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.”
Given the status of the pandemic, there are a large number of companies and researchers that are working to develop and evaluate potential therapies for COVID-19. To meet this urgent need the FDA has begun triaging requests from these parties and have provided rapid and interactive feedback to expedite the launch of clinical research.
According to the statement, the FDA has reviewed study protocols for multiple trials within 24 hours and has reviewed single-patient requests for expanded access within 3 hours.
The FDA has also deployed both medical and regulatory staff to serve on teams reviewing COVID-19 therapies. The agency has also modified processes and operations for developers and researchers sending requests as well as provided clinicians with resources to submit requests for emergency use of investigational products.
Several investigational therapeutics are currently being evaluated for safety and efficacy. Antiviral remdesivir is being assessed in clinical trials for treating COVID-19. Additionally, host targets including interleukin-6 (IL-6) receptor inhibitors are being evaluated for the reduction of lung inflammation and improvement of lung function in patients with COVID-19.
Investigators are also assessing whether convalescent plasma and hyperimmune globulin could decrease the length of illness or reduce the severity of symptoms.
Research is also ongoing to assess if existing therapies including chloroquine and hydroxychloroquine can help treat patients with COVID-19, both win and without additional medications.
“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,” Alex Azar, secretary of the Department of Health and Human Services said in the announcement.
You can read a review of COVID-19 treatment updates from Jason Pogue, PharmD, BCPS, BCIDP, and Erin K. McCreary, PharmD, BCPS, BCIDP,
