MPE encourages EMA to review its negative recommendation for ixazomib

Myeloma Patients Europe (MPE), in close collaboration with Myeloma UK, and along with almost 30 member and non-member associations across Europe, has submitted a letter to the Committee for Human Medicinal Products (CHMP) within the European Medicines Agency (EMA) to encourage them to reconsider the negative recommendation for ixazomib, and provide information to the appeal of their decision on ixazomib.

CHMP has expressed a negative opinion for ixazomib

Ixazomib (Ninlaro) has received a negative recommendation from the Committee for Human Medicinal Products (CHMP) within the European Medicines Agency. The CHMP is responsible for developing recommendations for the European Commission on new medicines going through the European marketing authorisation process. It assesses and makes recommendations on whether a drug is safe and effective enough to be granted a marketing authorisation for use across the European Union. Usually the European Commission follows the advice of…

EMA recommends market authorisation for elotuzumab

Elotuzumab receives a positive Committee for Medicinal Products for Human Use (CHMP) opinion for the treatment of multiple myeloma patients who have receive at least one prior therapy. The reccommensation is based in the results of a randomised open-label Phase 3 study evaluating the use of elotuzumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethashone alone. The results show that myeloma progresses more slowly on those patients who took elotuzumab compared to those…

EHA survey on unavailability of medicines

A website survey where doctors, patients and healthcare professionals can report unavailability of medicines has been developed. Over the course of (at least) the following months, these reports will be collected and analysed so that we can develop a coherent picture of the scope, causes and consequences of these problems in Europe. At the moment such an overview does not exist which makes it difficult for European politicians and policy makers to take measures that…

Lithuanian Presidency to start negotiations on clinical trials regulation

The Committee of Permanent Representatives (COREPER I) mandated the Lithuanian Presidency to enter into negotiations with the European Parliament and the Commission with the aim to reach an agreement at first reading on the Proposal for a Regulation on Clinical trials on medicinal products for human use, which aims to facilitate the conduct of clinical trials and thus increase their number in the EU, which could result in better treatment of patients.