Fast Track designation is a process that is meant to accelerate the development and expedite the review of medicines or drugs focusing on the treatment of serious indications and capable of addressing unmet medical requirements. The purpose of this designation is to find an important new treatment for early access to the patient. The Fast Track designation addresses a comprehensive range of severe disease indications.
In other words, the Fast Track designation process is made to facilitate the drug development, accelerate the Food and Drug Administration (FDA) review of drugs for serious indications, and address an unmet medical need.
Establishing whether a disease is serious or not is based on assessment. In general, the judgment is based on the drug’s ability to make an impact on factors such as day-to-day functioning and survival, among others. Also, if left untreated, the condition could progress from less severe disease to a more serious one.
Some examples of serious diseases that can progress to more severe levels, if left untreated, include Alzheimer’s disease, heart failure, cancers, and AIDS. Other conditions like depression, diabetes, and epilepsy are also considered to be serious.
The Fast Track program facilitates the expedited development and review of new drugs or biological drugs that are intended to-
Sponsors or drug developers usually apply for a Fast Track designation during the investigational new drug (IND) phase of drug development.
Any medicine that is being developed for treatment or prevention of an indication with no approved current treatment is directed at an unmet medical need. If there are already available treatments, a Fast Track drug must demonstrate a few benefits over the available treatment. These benefits include-
Fast Track designation is an approach to make a new drug quickly available for patients suffering from serious diseases. It could be considered as an approach to avoid the progression of a serious indication to become more severe or life-threatening. There are four approaches of FDA to make new drugs available as quickly as possible, and Fast Track designation is one of these four approaches.
The remaining three are priority review, breakthrough therapy, and accelerated drug approval.
After a drug receives Fast Track designation, it is eligible for some specific incentives. These incentives help drug developer to get early approval for that particular drug. The benefits are-
NDA or BLA review usually does not start till the drug manufacturer has submitted the complete application to the FDA.
Once a drug is granted Fast Track designation, early and regular interaction between the FDA and a drug manufacturer is encouraged during the complete drug development as well as the review process. The communication frequency confirms that questions and concerns are settled immediately, often leading to earlier drug approval and access of the drug by patients.
A pharmaceutical company or a sponsor that is manufacturing a drug to treat the condition with no existing therapy can request an application for Fast Track designation. The application can be started at any time throughout the process of drug development.
If the drug has significant advantages over existing therapies and the unmet medical need requirement is fulfilled, then also a drug manufacturer must apply the Fast Track designation.
After the application, the FDA will review the request and decide within two months based on whether the drug fulfils an unmet medical need in a serious indication.
Fast Track designation for a vaccine against ongoing life-threatening COVID-19
Pfizer Inc (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a vaccine for the ongoing pandemic. The companies announced that two of their four investigational vaccine candidates BNT162b1 and BNT162b2, from their BNT162 mRNA-based vaccine program, received Fast Track designation from the FDA. The vaccine developers stated that this designation was granted based on the initial data from Phase 1/2 clinical trials of BNT162 as well as animal immunogenicity studies.
With this designation, the vaccine developers got the opportunity to work closely with the FDA through the clinical development of their BNT162 mRNA-based vaccine program.
Bristol Myers Squibb Granted Fast Track designation for Opdivo (nivolumab) plus Yervoy (ipilimumab) Combination
Bristol Myers Squibb had received a Fast Track designation grant from the FDA for Opdivo plus Yervoy administered concomitantly for the first-line treatment of patients having metastatic or recurrent NSCLC (non-small cell lung cancer). Additionally, the FDA has also granted priority review to the combination of Opdivo plus Yervoy.