FDA Issues Guidances on Potential COVID-19 TreatmentsBy
The US Food and Drug Administration has issued guidance documents to help accelerate the development of prevention and treatment options for COVID-19. The FDA says the guidances make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.
In response to the COVID-19 pandemic, the FDA launched a new program called the Coronavirus Treatment Acceleration Program to help move new medical products to patients as soon as possible while at the same time determine whether they are effective and if the benefits outweigh the risks. To date (as of May 11, 2020), more than 130 clinical trials of potential COVID-19-related drugs and biological products are underway with FDA oversight and additional development programs for other agents are in the planning stages. The FDA has started to receive data from clinical studies and says it expects to receive more data regarding investigational products soon (as reported on May 11, 2020). The FDA says it intends to engage with pharmaceutical sponsors and other government partners to facilitate patient access as soon as possible when favorable results are observed.
The first guidance, COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products, outlines a process for developers to receive agency feedback on their supporting data with the goal of starting clinical trials. The FDA says it is committed to helping sponsors get potentially effective products into study. To that end, the guidance provides sponsors clarity on the types of data and information they should provide to address clinical, nonclinical, and quality considerations before submitting an application to initiate studies.
The second guidance, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, provides the FDA’s current recommendations on later-stage clinical trials intended to establish safety and effectiveness for COVID-19 products. The guidance outlines sponsor considerations, such as appropriate patient selection, including the evaluation of therapies in patients at high risk of complications from COVID-19. In addition, the guidance helps sponsors to understand how to design their trials, including considerations of study duration, assessment of efficacy, and monitoring for safety.
The FDA says these guidance documents are supplemented by a variety of ongoing activities and broad agency guidance to support innovative study designs, including master protocols, to test multiple products and multiple populations simultaneously and get answers on safety and efficacy.
Source: US Food and Drug Administration