Posted by Michael Wonder on 29 May 2019
Highlights from the CHMP 27-29 May 2019 meeting
29 May 2019 - EMA’s CHMP recommended four medicines for approval at its May 2019 meeting.
The Committee recommended granting a marketing authorisation for 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) for protecting the kidneys against radiation during radioactive therapy with lutetium (177Lu) oxodotreotide.
