Highlights of EMA/CHMP May meeting

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including two orphan medicines, at its May 28-31, 2018 meeting.

The CHMP recommended granting a marketing authorisation for Aimovig (erenumab), from Swiss pharma giant Novartis (NOVN: VX).the first human monoclonal antibody therapy for prevention of migraine. Aimovig belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide, a molecule that Save is involved in migraine attacks. Aimovig is the first treatment of its kind specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in migraine, commented Novartis.

The Committee recommended granting a marketing authorization for Tegsedi (inotersen), from Ionis Pharmaceuticals (Nasdaq: IONS), a medicine for patients with hereditary transthyretin amyloidosis that aims to affect the course of the disease and improve quality of life. This medicine was reviewed under EMA’s accelerated assessment mechanism, reserved for medicines of major public health interest. Tegsedi was designated as an orphan medicine during its development.