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

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. 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.

"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."

A total of 577 patients enrolled in ARISE were randomized to receive either placebo or AMG 334 at 70mg subcutaneously, once monthly. Patients experienced between four and 14 migraine days each month, with an average of eight migraine days per month at baseline. Those receiving AMG 334 experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, as compared to a 1.8-day reduction in the placebo arm.

The safety profile of AMG 334 was similar to placebo and consistent with previously-reported studies. The most common adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis.

Further analysis of the ARISE data is ongoing, and will be submitted to a future medical meeting and for publication. The STRIVE study, a second Phase III episodic migraine study evaluating both 70mg and 140mg doses of AMG 334 for 24 weeks, is expected to be completed by the end of this year. Positive results from a Phase II study of AMG 334 in chronic migraine prevention were also announced earlier this year.

Migraine is more than just a headache; it is the most prevalent of all neurological disorders and affects more than 10% of the worldwide population. Migraine has a profound and limiting impact on an individual's abilities to carry out everyday tasks, and was declared by the World Health Organization to be one of the top 10 causes of years lived with disability for men and women. People with episodic migraine experience up to 14 migraine days each month.

AMG 334 is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and the rest of the world.

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Publication:Mena Report
Date:Sep 29, 2016
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