Highlights of EMA/CHMP September meeting

21 September 2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its September 2018 meeting recommended 13 medicines for approval, including three orphan medicines that are covered in a separate article.

The CHMP recommended granting a marketing authorization for Emgality (galcanezumab), Eli Lilly’s (NYSE: LLY) monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks.

Emgality is the second monoclonal antibody therapy for the prevention of migraine to be recommended for authorization, following the positive opinion for Amgen (Nasdaq: AMGN) and Novartis’s (NOVN: VX) Aimovig (erenumab) in May 2018.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK