From their meeting in May, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced recommendations for four medicines for approval.
A marketing authorisation was recommended for Cufence (trientine dihydrochloride) for the treatment of Wilson’s disease which is a rare inherited disorder that causes copper to accumulate in vital organs such as the liver and brain. During the development of Cufence, it was designated as an orphan medicine.
A negative opinion recommending the refusal of a marketing authorisation was adopted by the CHMP for Xyndari (glutamine). This medicine was intended to be used to treat sickle cell disease.
At the request of the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, a review of the effectiveness of medicines containing a combination of methocarbamol and paracetamol for the treatment of painful muscle spasms has been initiated.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.