Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorization for AJOVY® (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. If approved by the European Commission (EC), AJOVY, a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, will be the first and only anti-CGRP treatment in the European Union (EU) with both quarterly and monthly dosing options.
Migraine is a disabling neurological disease often accompanied by nausea, vomiting, photophobia, phonophobia and changes in vision.1 Globally, there are approximately one billion people affected by migraine2, with more than 50 million people suffering from the disease across Europe.3 It is estimated that the total annual cost of migraine in Europe is €111 billion.4
“We are very pleased to report a positive opinion by the CHMP,” said Richard Daniell, Executive Vice President, European Commercial at Teva. “This is another important milestone for us and the migraine community as a whole. We hope to expand the availability of AJOVY to the EU so that eligible patients can potentially benefit from the flexibility AJOVY offers through quarterly and monthly dosing options.”
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