3:26 PM
Dec 05, 2018
 |  BC Extra  |  Politics & Policy

FDA breaks NME approval record in 2018

FDA has approved 55 new molecular entities so far in 2018, surpassing in mid-October the total of 46 that were approved in 2017. With almost four weeks left in the year, 2018 has already topped the 53 that were approved in 1996, the all-time high in FDA's published data.

Approvals of Orphan drugs shot up to 32, exceeding the total number of approvals for all but eight of the past 26 years. Last year's total was 18. About a third of the Orphan drugs were approved for cancer indications; only three of this year's cancer approvals were for non-Orphan cancers.

Breakthrough therapy-designated NME approvals fell to 13 so far this year from 17 in 2017. There have been five approvals of Qualified Infectious Disease Products (QIDP), up from three.

Were FDA to keep pace in December with its average of five approvals a month, the agency would hit 60 approvals in 2018.

According to BioCentury's BCIQ database, at least three products with potential to be categorized as NMEs have PDUFA dates remaining in December: solriamfetol (JZP-110), prucalopride (SHP-555) and calaspargase pegol (SHP-663).

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is developing solriamfetol to treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea; it has Orphan Drug designation to treat narcolepsy. Shire plc (LSE:SHP; NASDAQ:SHPG) is developing the other two: prucalopride to treat chronic idiopathic constipation and calaspargase pegol to treat acute lymphoblastic leukemia (ALL). In October, FDA's Gastrointestinal Drugs Advisory Committee recommended prucalopride's approval; Shire markets it in Europe as Resolor.

Additionally, sacituzumab govitecan from Immunomedics Inc. (NASDAQ:IMMU) has breakthrough therapy designation to treat metastatic triple-negative breast cancer. Its PDUFA date is in January, but an approval could come sooner.

NMEs include products reviewed under an NDA containing a new chemical entity (NCE), including combination products in which at least one component is an NCE; and products reviewed under a new BLA by the Center for Drug Evaluation and Research (CDER). Products reviewed by the Center for Biologics Evaluation and Research (CBER), which include cell therapies, are not considered NMEs.

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

Purchase this article for limited one-time distribution and website posting

$750 USD