EMA’s CHMP Recommends Six Medicines for Approval
Posted 19 October 2018 | By
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced the recommendation of six medicines for approval, including two orphan medicines, as well as three extensions of indications and a new vice-chair.
Of the six medicines, at its October meeting, CHMP recommended granting an authorization for Shire’s Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema. The orphan medicine is already approved in the US and was reviewed under EMA's accelerated assessment procedure.
In addition, the committee recommended granting a marketing authorization for Lupin’s orphan medicine 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 authorized EU-wide, EMA said, though the active substance mexiletine has been approved for treatment of these disorders in France only since 2010.
CHMP recommended granting a marketing authorization for Sanofi’s Dengvaxia (dengue tetravalent vaccine (live, attenuated)), the first vaccine in the EU for the prevention of dengue. The vaccine has been at the center of a controversy in the Philippines as safety concerns arose from a school vaccination program and the company later pulled the vaccine from the market (here’s more from WHO
The committee also adopted a positive opinion for Seqirus Netherlands' 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, for AstraZeneca's Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate), for maintenance treatment of chronic obstructive pulmonary disease (COPD) and for Mylan's biosimilar medicine Ogivri (trastuzumab) for the treatment of breast and gastric cancer.
The committee recommended extensions of indication for Kalydeco, Keytruda and NovoSeven.
And Professor Bruno Sepodes from Portugal was announced as CHMP’s new vice-chair, for a three-year mandate, starting on 15 October 2018. Sepodes is a member of the evaluation board of medicines at the Portuguese national competent authority, known as the National Authority for Medicines and Health Products (INFARMED). He has been a member of CHMP since 2012.