EMA's CHMP recommends six new medicines for approval

At its October 2018 meeting this week, the European Medicines Agency’ Committee for Medicinal Products for Human Use (CHMP) issued recommendations for the approval of six new medicines, meaning they are on track for final approval in the next two or three months.

Among these, the CHMP recommended granting marketing authorization for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE), from Ireland-headquartered Shire (LSE: SHP). Takhzyro was reviewed under EMA's accelerated authorization procedure, reserved for medicines of major public health interest.

The Committee recommended granting a marketing authorization for Namuscla (mexiletine hydrochloride), from India-based Lupin (BSE: 500257), for the treatment of myotonia in adult patients with non-dystrophic myotonic disorders. This is the first treatment for this disease to be authorized European Union-wide. Namuscla was designated as an orphan medicinal product in November 2014.