Novartis announces Phase III study shows AMG 334 significantly reduces monthly migraine days in people with episodic migraine

Novartis International AG / Novartis announces Phase III study shows AMG 334 significantly reduces monthly migraine days in people with episodic migraine . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• ARISE, first pivotal Phase III study of AMG 334 (erenumab) in episodic migraine prevention, met primary endpoint, showing a statistically significant reduction in monthly migraine days vs placebo
   

People with episodic migraine experience up to 14 migraine days each month and lose a substantial part of their lives to this debilitating disease
 

AMG 334 is being co-developed by Novartis and Amgen

Basel, September 28, 2016 - Novartis today announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention. The study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with AMG 334 compared with placebo at 12 weeks.[1] AMG 334 is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor that is believed to have a critical role in mediating the incapacitating pain of migraine.[2]

"People who suffer from episodic migraine experience substantial pain, disability and physical impairment, which can significantly disrupt their ability to participate in everyday activities," said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. "The positive results from ARISE are especially encouraging because there are currently no treatment options specifically designed for the prevention of migraine. These findings, in combination with the recent positive data in chronic migraine prevention, add to the growing body of evidence that shows AMG 334 has the potential to help individuals worldwide suffering from episodic and chronic migraine."