Novartis Gets EU Nod for First-Of-Its-Kind Migraine Drug

   By Olivia Bugault and Donato Paolo Mancini 
 

An innovative migraine treatment co-developed by Novartis AG (NOVN.EB) has been approved for use in the European Union, paving the way for the Swiss pharmaceutical to be the first to the multibillion-dollar migraine-treatment market in Europe.

The drug, Aimovig, was developed in collaboration with Amgen Inc. (AMGN). It is the first approved migraine-prevention treatment designed to specifically block a receptor that is key to the manifestation of the condition, Novartis said late Monday.

Data to support the approval comes from a clinical program of 2,600 patients. The drug also proved effective in "difficult-to-treat" patients for whom two to four common migraine treatments had proved ineffective.

"A treatment specifically designed for migraine prevention is a much-welcomed innovation and could transform lives of patients for whom current therapies do not work or are not well tolerated," said Patrick Little, president of the European Migraine and Headache Alliance.

French bank Bryan Garnier estimates that Aimovig will rake in around $1 billion in revenue by 2024.

Prior to receiving European Commission approval, Aimovig was approved by the U.S. Food and Drug Administration last May. Already approved in Switzerland and Australia, the drug will soon be sold to the 28 European member states plus Iceland, Norway and Liechtenstein.

Migraines are estimated to affect 37 million people in the U.S. alone, and to cost up to about 27 billion euros ($31 billion) in Europe, according to academic research studies.

Competitors like Teva Pharmaceutical Industries Ltd. (TEVA.TAE) and Eli Lilly & Co. (LLY) are developing similar drugs, but market entry for these isn't expected until year's end. Allergan PLC (AGN) is expected to launch an oral formulation competitor in 2020.

Write to Olivia Bugault at [e-mail] and to Donato Paolo Mancini at [e-mail]

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(END) Dow Jones Newswires

July 31, 2018 11:33 ET (15:33 GMT)

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