Six medicines recommended for approval, including two orphan medicines
The CHMP recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE). This medicine was reviewed under EMA’s accelerated assessment procedure, reserved for medicines of major public health interest. For more information, please see the press release in the grid below.
The Committee recommended granting a marketing authorisation for Namuscla (mexiletine hydrochloride), for the treatment of myotonia in adult patients with non-dystrophic myotonic disorders. This is the first treatment for this disease to be authorised EU-wide. For more information, please see the press release in the grid below.
The CHMP recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), the first vaccine in the EU for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection. For more information, please see the press release in the grid below.
The Committee adopted a positive opinion for Flucelvax Tetra (influenza vaccine surface antigen inactivated prepared in cell cultures), intended for the prevention of influenza in adults and children from 9 years of age.
The CHMP also recommended the granting of a marketing authorisation for Bevespi Aerosphere(glycopyrronium / formoterol fumarate dihydrate), for maintenance treatment of chronic obstructive pulmonary disease (COPD).
Three recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Kalydeco, Keytruda and NovoSeven.
CHMP elects new vice-chair
The Committee elected Professor Bruno Sepodes from Portugal as its new vice-chair, for a three-year mandate, starting on 15 October 2018. Professor Sepodes replaces Dr Harald Enzmann, who was elected as CHMP Chair at the September 2018 CHMP meeting. Bruno 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). He has been a member of the CHMP since 2012. In parallel to his involvement in the CHMP, he was also the Chair of EMA’s Committee for Orphan Medicinal Products (COMP) from 2012 to 2018.