FDA Novel Drug Approval Trends

Prescription drugs must be approved by the United States Food and Drug Administration (FDA) before entering the market. Each year, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approve a wide range of new drugs and biologics. These products can either be drugs that have never been used in clinical practice before or drugs that are similar to previously approved products. As of 8/25/2023, the FDA has approved 35 drugs. This is almost the same number of drugs approved in all of 2022!

Although it seems there is a recent increase in drug approvals this year compared to 2022, the current trend of 2023 is on par with the past five years, excluding 2022. The table below shows data from the past five years of novel drug approvals from the FDA.

There is not a clear reason why there were significantly fewer approvals in 2022. However, there is speculation that it has to do with 2021 controversies that led to a more stringent approval process. When a drug is rejected, the FDA does not publish the complete response letter (CRL) and leaves the disclosure of the FDA’s response up to the applicant. The FDA does not publish figures for rejected applications. Theoretically, the decrease in approvals in 2022 could be due to more drug application rejections than normal.

Even with fewer drug approvals in 2022, the percentage of drugs approved using an expedited development pathway is similar to previous years. The four main pathways to expedite a drug’s review and/or approval are as follows:

• Fast Track – Facilitates the development and expedites the review for drugs treating serious conditions with an unmet medical need.
• Breakthrough Therapy – FDA expedites the review process for drugs that demonstrate substantial improvements over available therapies.
• Priority Review – FDA implements a goal to review and take action on the application within 6 months vs. 10 months for a standard review.
• Accelerate Approval – Drug approvals serious conditions with an unmet medical need may be approved based on a surrogate endpoint.

The manufacturer of a single product may request review/approval via multiple pathways above. Until the complete counts are shared, it is difficult to assess the FDA approval trends based on these pathways.  With that being said, the products that have been approved do not focus on one disease state or area of practice. The drugs approved in 2023 treat a variety of diseases ranging from common diagnoses like migraines to rare diseases like Fabry disease. However, rare diseases are becoming a growing target for drug development.

How do you think these trends will continue or change over the next five years?

Posted August 30, 2023

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