Fast Track Approval

Fast track approval is a method used to facilitate development and review of drugs for treating serious health conditions and to meet an unmet medical requirement. The main purpose of this process is to get essential new drugs to the patients earlier. Fast track address a wide range of serious health conditions.

The determination of a serious condition depends upon its impact on survival, daily functioning or likelihood and if it is left untreated, it will progress from a minimal severe condition to a severe one. Conditions like Alzheimer’s, heart failure, AIDS and cancer are some examples of serious health conditions. Apart from these, diseases like depression, diabetes and epilepsy are also among the serious conditions.

Filling of an unmet medical need means providing a therapy which has significant potential over an existing therapy or providing a therapy for an unmet medical condition.

Any drug which is being developed for treating or preventing a medical condition for which there is no available therapy, is directed for an unmet need. If there are existing therapies, then a fast-track drug should show some benefits over the existing one, like:

• It is showing superior effects or improved effects on serious outcomes.
• It avoids some major side effects of the existing therapy.
• The early diagnosis results in improved outcome.
• Decreases the toxicity of the available therapy which can cause discontinuation of treatment.
• It can anticipate public health need.

Fast Track approval is requested by the drug company and can be raised at any time of the development process. Once the request is made, FDA will review and make decision within 60 days depending upon whether the drug meets an unmet medical need in a serious health condition.

When a drug gets a Fast-Track designation from FDA, frequent and early communication is encouraged between FDDA and the drug company throughout the drug development and review process. This ensures that the issues and queries are resolved timely, which leads to an early drug approval and access to the patients.

A drug on receiving a Fast-track approval is eligible for some or all the following things:

• Forewent meetings are held with FDA for discussing the development plan and to ensure collection of data needed for supporting drug approval.
• Frequent written communication from FDA related to clinical trial designs and use of.
• If relevant criteria are met, it can be eligible for Accelerated Approval and Priority Review.
• Rolling Review, which means that the drug company can submit completed sections of Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, instead of waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

Some of the drugs that got fast-track approval for a certain serious condition are:

• Coartem (artemether/ lumefantrine) got fast-track approval for treatment of Malaria
• Emtriva (emtricitabine) got fast-track approval for treatment of HIV.
• Somavert (pegvisomant) got fast-track approval for treatment of acromegaly.