On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19. With these documents, the Agency intends to establish a more efficient process for submitting applications to initiate studies for new drugs and biological products, “and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.”
Guidance #1: Requesting and Conducting Pre-IND Meetings for COVID-19 Related Drugs and Biological Products
The first guidance document, entitled COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products, assists Sponsors through the Pre-IND stage by providing them with a more efficient process to obtain the FDA’s feedback on their supporting data for their IND submission. Given that time is of the essence, the goal of this guidance is to help Sponsors get their clinical trials started as quickly as possible.
In addition, this guidance document also provides additional information regarding the types of data and information that Sponsors should provide in order to address clinical, nonclinical, and quality considerations before submitting an IND application.
The major takeaways from this guidance document are as follows:
- FDA is strongly suggesting that Sponsors submit a meeting request and briefing package as their first step rather than jumping right into an IND submission or submitting a pre-Emergency Use Authorization The Agency states that this “can lead to more rapid review of the subsequent IND and assurance of subject safety, which in turn can facilitate faster clinical trial initiation for programs that proceed to that phase.”
- During the COVID-19 pandemic, the Agency is consolidating the pre-IND meeting request and package development process into one single step.
- Even if a sponsor has an active IND for another indication, the FDA recommends submitting a separate COVID-19 pre-IND meeting request and package which will help FDA to identify and prioritize the requests in response to the public health emergency.
- The guidance provides a description of the general contents of the pre-IND meeting request and package that is more streamlined and tailored to COVID-19 than the contents described in the Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry.
- FDA encourages sponsors to submit a draft clinical protocol in the meeting package that includes phase of development, mechanism of action, overall design, subject population with inclusion and exclusion criteria, endpoint(s), safety assessments, and brief statistical considerations.
- Notably missing from the Guidance is a timeline for a response to the meeting request or for scheduling the meeting. If granted, the meeting will be Written Responses Only.
Guidance #2: Developing Drugs and Biological Products to Treat or Prevent COVID-19
The second guidance document, entitled COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, focuses on later stage clinical trials that intend to demonstrate safety and effectiveness for products to treat or prevent COVID-19. In a recent statement, FDA notes that the document outlines critical considerations for Sponsors, including “appropriate patient selection, including the evaluation of therapies in patients at high risk of complications from COVID-19 (e.g., the elderly). 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 Agency’s goal in issuing this guidance was to assist Sponsors in designing studies as efficiently as possible, hopefully leading to the review and approval of safe and effective drugs and biologics to combat the current global health crisis.
However, it is important to note that in the guidance document, the Agency states that its recommendations do not apply to preventative vaccines and convalescent plasma.
The major takeaways from the second guidance document are as follows:
- FDA is encouraging Sponsors to include a broad and diverse population in the trial from the perspective of disease severity, underlying health status, age, race/ethnicity, etc.
- Additional guidance is provided on categorizing baseline severity.
- Randomized, placebo-controlled, double-blind clinical trials using a superiority design are recommended.
- FDA acknowledges that the clinical landscape surrounding treatment of COVID-19 is changing rapidly and anticipates that revisions to trial designs may be necessary.
Right now, the development of drugs and biological products for the treatment and prevention of COVID-19 is the Agency’s top priority. FDA is dedicated to finding a cure for the disease as well as a way to protect the public from future outbreaks by preventing the disease from returning and infecting mass quantities of people. If you are in the process of developing a drug or biologic to treat or prevent the coronavirus, we can help get your product in front of the FDA as quickly and effectively as possible. We have extensive experience helping our clients work their way through the development process, accomplishing each developmental milestone and achieving successful interactions with the FDA along the way.
For more information on our qualifications and capabilities and to learn how we can help you, contact us today.
