In 2021, the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved 50 new drugs, either as new molecules (NMEs) under the New Drug Applications (NDAs), or as new therapeutic drugs under the Biologics License Application (BLAs). The FDA summarizes these recommendations in their recently released report: Advancing Health Through Innovation: New Drug Therapy Approvals, 2021.
Based on recent developments, 2021 can be seen as the middle year in the new era. Between 2012-2020, the number of approved drugs was 42.2 (average: 45). As a result, we can see 2021 as a middle year. This can be considered primarily due to the reduction that may occur in clinical trials due to COVID-19.
Interestingly, 76% (n = 38/50) of drugs approved in 2021 were approved in the US before any other country. Some of these are due to the FDA’s speed with respect to other regulatory agencies around the world. The FDA states that 86% of approved drugs were approved in their original form; The FDA states that this “demonstrates how CDER staff clearly inform pharmacists about the basic research requirements and other requirements for drug use in order to provide comprehensive and comprehensive evaluation of drugs”. However, one of the reasons why so many new drugs are being introduced in the US is because of pharmaceutical companies that have chosen to approve the US, which is the largest pharmaceutical market in the world.
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One might be concerned that most of the accepted ones were “me too” drugs. However, we note that more than half (54%, n = 27/50) approved were first in the class. Approval included (Adbry, Aduhelm, Besremi, Brexafemme, Bylvay, Cosela, Cytalux, Gals, Evkeeza, Kerendia, Korsuva, Leqvio, Livtencity, Lumakras, Lupkynis, Nulibry, Rezurock, Rybrevantv, Zaspinev, Taspinev, Taspine Vs. ). Interestingly, 52% of admissions (n = 26/50) received a sign of orphan prescription.
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- Speed speed (36%). Fast Track accelerates new drug development and review by enhancing communication between FDA and drug manufacturers as well as allowing CDER to review drug levels more frequently. The drugs were Aduhelm, Amondys 45, Brexafemme, Bylvay, Cabenuva, Cytalux, Asiveli, Exkivity, Kerendia, Lumakras, Lupkynis, Nexviazyme, Rylaze, Saphnelo, Scemblix, Truseltiq, Verquvo, Vyvgart
- Support Method (28%). Breakthrough Therapy terms incorporate all aspects of the Fast Track program and provide strong FDA guidance on drug development. Suitable drugs were Cosela, Evkeeza, Exkivity, Jemperli, Korsuva, Livmarli, Livtencity, Lumakras, Nexviazyme, Nulibry, Rezurock, Rybrevant, Scemblix, Ukoniq.
- Extra Light (68%). The drug receives Higher Screening if the CDER considers the drug to be effective in improving treatment. This means that CDER intends to take action on drug use within six months of enrollment (compared to 10 months of follow-up).
- Accelerated approval (28%). The Approved Approach gives the FDA greater flexibility in the end-to-end use of drugs that provide benefits for the modern treatment of acute or chronic diseases. Accurate endpoints may include those that are “possible” medical predictions, which may enable the drug to show benefits in the short term (while long-term benefit manifestations need to be culturally acceptable). The following validation tests should be performed to support traditional acceptance. The program seeks to bring in products that can provide much-needed immediate relief for sale in addition to traditional licenses. Approved drugs under this route include: Aduhelm, Amondys 45, Exkivity, Jemperli, Lumakras, Pepaxto, Rybrevant, Scemblix, Tepmetko, Tivdak, Truseltiq, Ukoniq, Voxzogo, Zynlonta.
The FDA also approved 4 new biosimilar products in 2021. Since 2015, the FDA has approved 33 biosimilar drugs for 11 different drugs.