Modest four recommendations from EMA/CHMP May meeting

30 May 2019

At its May 27-29 meeting, the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) recommended four medicines for approval, and gave two negative opinions.

The Committee recommended granting a marketing authorization for Univar BV’s Cufence (trientine dihydrochloride), for the treatment of Wilson’s disease, a rare inherited disorder that causes copper to accumulate in the liver, brain and other vital organs. Cufence was designated as an orphan medicine during its development.

The CHMP granted a positive opinion for LysaKare (Arginine/lysine), from Advanced Accelerator Applications, which is part of Novartis (NOVN: VX), for protecting the kidneys against radiation during radioactive therapy with lutetium (177Lu) oxodotreotide.

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