3:26 PM
Jan 08, 2019
 |  BC Extra  |  Politics & Policy

CHMP recommendations of new active substances up in 2018

EMA said on Friday that the agency's CHMP recommended for approval 42 new active substances in 2018, up seven from 35 in 2017 and its highest total since at least 2013.

The recommendations include 11 cancer drugs, six for infectious diseases and five for neurology indications. By BioCentury's count, the European Commission has so far approved 37 of the 42 new active substances, with five still under review.

Products under review include Erleada apalutamide from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) to treat non-metastatic castration-resistant prostate cancer (CRPC) and Rizmoic naldemedine from Shionogi & Co. Ltd. (Tokyo:4507) to treat opioid-induced constipation.

FDA ended 2018 with a record 59 new molecular entity approvals (see "FDA Closes 2018 with Record NME Approvals").

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