Btobioinnovation.com

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #1

The US FDA has approved 59 NMEs (new medical entities) in 2018 topping its previous record of 53 in 1996.

This impressive showing follows a 46 NMEs approvals in 2017 and a low 22 new approvals in 2016. Observers are indicating that, without the partial government shutdown which took effect on December 22, the number of approved drugs may have exceeded the 60 figure.

Similar to last year, oncology drugs came up on top with 16 approvals including four genetically defined cancers.

The agency also approved more than 10 new drugs for the treatment of rare diseases.

Amgen and Novartis, as well as Teva and Eli Lilly’s got approvals for drugs acting as CGRP inhibitors, a new class of treatment which represent an attractive option for migraine patients.

Pfizer ended up with four new approvals all in oncology. AstraZeneca, Bayer, Eli Lilly, Novartis, Shionogi and Shire, got two approvals. For the second year in a row, Bristol Myers Squibb was the only top 15 pharma without a US FDA approval

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