EMA Recommends Six Medicines for Approval

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The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indication.

The European Medicines Agency (EMA) announced on Oct. 19, 2018 that its Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval during its October 2018 meeting. 

CHMP recommended granting a marketing authorization for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE), according to the agency. This medicine was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest.

The committee recommended granting a marketing authorization for Namuscla (mexiletine hydrochloride), for the treatment of myotonia in adult patients with non-dystrophic myotonic disorders. EMA reports that Namuscla is the first treatment for this disease to be authorized European Union-wide. CHMP also recommended the granting of a marketing authorization for Bevespi Aerosphere (glycopyrronium/formoterol fumarate dihydrate) for maintenance treatment of chronic obstructive pulmonary disease.

Dengvaxia (dengue tetravalent vaccine (live, attenuated) was recommended for a marketing authorization. This is 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. The committee also adopted a positive opinion for Flucelvax Tetra (influenza vaccine surface antigen inactivated prepared in cell cultures) for the prevention of influenza in adults and children from nine years of age.


Biosimilar Ogivri (trastuzumab) received a positive opinion from the CHMP for the treatment of breast and gastric cancer. Extensions of indication for Kalydeco, Keytruda, and NovoSeven were also recommended.

Source: EMA