CHMP Recommends Six Medicines for Approval

The EMA’s Committee for Medicinal Products for Human Use recommended six medicines for approval at its October meeting.

The committee recommended marketing approval for Shire’s Takhzyro (lanadelumab), the first monoclonal antibody therapy for preventing recurring attacks of hereditary angioedema.

The expert panel also issued positive opinions for Lupin’s Namuscla (mexiletine hydrochloride), a treatment for adults with non-dystrophic myotonic disorders, and AstraZeneca’s maintenance treatment for chronic obstructive pulmonary disease, Bevespi Aerosphere (glycopyrronium/formoterol fumarate dihydrate).