www.fdanews.com/articles/176492-chmp-recommends-six-drugs-in-eu-one-outside-eu
CHMP Recommends Six Drugs in EU, One Outside EU
May 5, 2016
The EMA’s Committee for Medicinal Products for Human Use is recommending approval for six drugs within the EU and another for export-only from EU countries.
Among those drugs earning CHMP’s recommendation is AstraZeneca’s Zavicefta, which represents one of only a few treatment options available to patients with infections caused by certain Gram-negative bacteria.
Additionally, Bial’s Ongentys for the treatment of Parkinson’s disease and motor fluctuations, Allergan’s Enzepi for the treatment of exocrine pancreatic insufficiency, and Isotope Technologies’ radiopharmaceutical precursor Endolucinbeta have nabbed favorable recommendations.
CHMP also backed Biogen and AbbVie’s multiple sclerosis treatment Zinbryta.