From their meeting in October, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting, the CHMP announced the recommendations of six medicines for approval, including two orphan medicines. A new vice-chair of CHMP was also elected.
CHMP recommended granting an authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema. The orphan medicine was reviewed under EMA’s accelerated assessment procedure and is already approved in the United States (US). The CHMP also recommended granting a marketing authorisation for the orphan medicine Namuscla (mexiletine hydrochloride), for the treatment of myotonia in adult patients with non-dystrophic myotonic disorders. Namuscla is the first treatment for this disease which is authorised EU-wide, although the active substance mexiletine has been approved for treatment of these disorders in France since 2010.
A positive opinion was adopted for Flucelvax Tetra (influenza vaccine surface antigen inactivated prepared in cell cultures), which is intended for the prevention of influenza in adults and children from 9 years of age.
CHMP recommended extensions of indication for Kalydeco, Keytruda and NovoSeven.
The CHMP have elected Professor Bruno Sepodes from Portugal as their new vice-chair, for a three-year mandate which started on 15th October 2018. Professor Sepodes is a member of the evaluation board of medicines at the Portuguese national competent authority; the National Authority for Medicines and Health Products (INFARMED). Since 2012, he has been a member of the CHMP and as well as his involvement in the CHMP, he was also Chair of EMA’s Committee for Orphan Medicinal Products (COMP) from 2012 to 2018.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.