Report: NDA, BLA Approvals by FDA Fell 16 Percent in 2019

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Report: NDA, BLA Approvals by the FDA Fell 16% in 2019

 

A new report released on Tuesday by GlobalData suggested that there was a 16% decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration (FDA) last year.

According to the 10th edition of GlobalData’s pharmaceutical contract manufacturing organization industry report, “PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2020 Edition,” the FDA accepted 119 NDAs and biologics license applications (BLAs) in 2019, including new molecular entities (NMEs) and new formulations of existing drugs. This was a 3% increase from the 2014-2018 period that saw an average of 115 approvals, but a 16% decrease from the 137 approvals recorded back in 2018.

The report also indicates that small cap companies continue to outsource their products, compared to other market cap groups. For example, 79% of NMEs and 67% of non-NME NDAs sponsored by small caps were outsourced over the last decade.

However, 44 FDA NDAs were outsourced to contract manufacturers in 2019, which is lower than the 2014-2018 average of 55.6.

“Apart from a large proportion of approvals being sponsored by mega cap companies, the number of FDA novel approvals had also declined since 2018, with the U.S. Government shutdown in January 2019 causing a reduction in FDA approvals in 2019, where the FDA suspended reviews of existing Investigational New Drug (IND) and BLA applications,” said Adam Bradbury, Associate Healthcare Analyst at GlobalData. “These factors combined account for the low number of outsourced products.”

According to historical findings, the large amount of mega cap approvals will not become a trend, and the number of NDA approvals will continue to fluctuate from year to year.

“It is difficult to predict in these unprecedented times how the COVID-19 crisis could impact drug approvals, pharma CMOs and global supply chain networks, but 2020’s FDA approval numbers may be substantially affected depending on how well the crisis is handled,” Bradbury added.

Many experts have already begun to speculate how the COVID-19 pandemic will affect NDAs and the overall development of products that are not specifically designed for the treatment of the novel coronavirus.

Ken Kaitin, who directs the Tufts Center for the Study of Drug Development, recently told NPR that he believes those who are waiting for a new drug will have to be patient. Many clinical trials have been put on hold as a result of the COVID-19 pandemic, creating a backlog of drugs that need to be further studied.

However, new findings from a cross-sectional analysis of 273 drugs and biologics approved by the FDA over the past three decades show that there has been a shift in the federal standard for marketing approval. The analysis, which was published in JAMA Network Open back on April 21, suggests that more recent approvals were based on fewer pivotal trials.

“This change has implications for physicians and patients as they consider using newly approved drugs as well as for regulators, given that it suggests an increasing need for continued evaluation of therapeutic safety and efficacy after approval,” concluded the authors of the study.

Since the introduction of the Fast Track designation by the FDA, the number of special regulatory programs available for the approval of new drugs and biologics has increased. That being said, the authors of the report believe that there is an “ongoing need for the continued evaluation of therapeutic safety and efficacy” after a drug has been given the green light.

 

BioSpace source:

https://www.biospace.com/article/report-nda-bla-approvals-by-the-fda-fell-16-percent-in-2019