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Regulatory Focus™ > News Articles > 2020 > 2 > Updated: Striking While the Iron is Hot: FDA Corrects New NDA, BLA Filings in Q1 of FY 2020

Updated: Striking While the Iron is Hot: FDA Corrects New NDA, BLA Filings in Q1 of FY 2020

Posted 18 February 2020 | By Zachary Brennan 

Updated: Striking While the Iron is Hot: FDA Corrects New NDA, BLA Filings in Q1 of FY 2020

As the US Food and Drug Administration (FDA) continues to approve more new drugs more quickly, the number of new application filings in the first quarter of FY 2020 (through 31 December 2019) seemed at first to have increased dramatically when compared to FY 2019 and 2018.

FDA initially said this latest quarter saw 74 new drug application (NDA) filings and 32 biologics license application (BLA) filings, which compared with a total of only 26 BLA filings in all four quarters of 2019 and a high of 51 NDA filings in Q1 of 2019. By comparison, FDA saw an average of 35 quarterly NDA filings across FY 2019 and 34.25 across FY 2018, while quarterly BLA filings averaged 6.5 in FY 2019 and 5.25 in FY 2018.

Five days after this article was originally published on 5 February, "On February 10, 2020, the data was updated to exclude CDER efficacy supplements (41 NDAs and 22 BLAs) that were inadvertently included in the filed counts," FDA's latest version of the quarterly report says. 

Peter Stein, director of the FDA's Office of New Drugs (OND), recently spoke to Focus and noted the rise of cancer drug applications, especially for subtypes of cancers and rare cancers where there have been some "dramatic responses." 

EMA vs. FDA

study found that the European Medicines Agency (EMA) and FDA disagreed on approvals in only limited circumstances from 2014 to 2016, but more recently, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted negative opinions for two drugs in 2018 that were approved by FDA in 2017, and one sickle cell drug in 2019 that was also previously approved by FDA.

In addition, CHMP raised questions about Mitsubishi Tanabe Pharma’s treatment for amyotrophic lateral sclerosis, which withdrew its application this year, and which was approved by FDA in 2017. And EMA refused to approve Bristol-Myers Squibb’s Idhifa (enasidenib) based on a single-arm study and the company withdrew its application. But FDA approved the treatment in 2017.

Roche also said EMA wants more data for its spinal muscular atrophy treatment risdiplam "before approval (perhaps with broader indication) and we may have a policy difference with broad implications,” Bernstein biotech analyst Ronny Gal said in an investor note this week, pointing to differences between FDA and EMA.

FDARA Section 903 Real Time Quarterly Reports

Editor's note: FDA provided an updated quarterly report to Focus, showing the initial Q1 statistics were inflated with supplement data. 

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