2021 New Drug Approvals, By The Numbers

Last week, the FDA's Center for Drug Evaluation and Research released it 2021 report of New Drug Therapy Approvals. The approvals are notable for the potential to provide a positive impact on patient care. The following infographic shows some of the more notable statistics from this year's report.

According to the FDA, CDER approved 50 new drugs in 2021. The applications represented both new molecular entities under New Drug Applications or new therapeutic biologics under Biologics License Applications. In each case, the active ingredient or ingredients have never been approved in the U.S.

New drugs advance treatment options in heart, blood, kidney and endocrine disease; autoimmune, inflammatory and lung diseases; infectious disease; neurological and psychiatric disorders; cancer; and other orphan conditions.

98 percent of the approvals were granted within the Prescription Drug User Fee Act timeframes and nearly 90 percent were approved on the first cycle. The FDA credits this with earlier and more effective communication between manufacturers and the FDA. It is also likely due to the use of expedited approval pathways, including "fast track" and "breakthrough therapy" designation along with "priority review" and "accelerated approval."

Of note, CDER approved four new biosimilar products and the first two interchangeable biosimilar products, marking continued advancement in this market segment. Beyond novel drug approvals, the FDA approved 12 new formulations of drugs that had been previously approved. These include new formulations, new dosage forms and other non-novel drug approvals.

This report should be of interest to drug manufacturer, particularly given the level of coordination and collaborations needed to secure approval for new drugs. The FDA report shows that an effective, team-base collaboration with the FDA and other experts can lead to timely approval of safe and effective therapies for a wide range of medical conditions. We listen to their concerns and strive to see their perspectives. We know it is important to understand the needs of our key constituencies and take actions that will benefit as many Americans as possible.

For more information about this report, contact me at john@policypros.net

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