Novartis and Amgen plan to file migraine jab

Novartis and Amgen could submit their new monthly migraine injection with regulators next year, after the drug succeeded in a second late-stage trial.

They announced positive topline results from the global phase 3 STRIVE study of erenumab, also known as AMG 334, in episodic migraine prevention.

The companies said they are analysing data from a phase 2 trial, and an earlier phase 3 trial that has already reported results.

They said they plan to discuss data with regulators, and aim to file the drug in 2017.

Analysts EP Vantage expects erenumab to bring in sales of almost $500 million in 2022 if approved, although a rival drug being developed by Teva could bring in sales north of a billion by that time.

AMG 334 is being co-developed by Amgen and Novartis. Amgen has marketing rights in the US, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world if approved.

Once-monthly subcutaneous AMG 334 was evaluated at 70mg and 140mg doses, with both doses meeting the study's primary endpoint, showing a statistically significant reduction from baseline in mean monthly migraine days at six months versus placebo.

AMG 334 is designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor that is believed to have a critical role in mediating the incapacitating pain of migraine.

Novartis’ chief medical officer and head of drug development, Vasant Narasimhan, said: "We have now seen positive results with AMG 334 from two phase 3 studies in episodic migraine and the phase 2 study in chronic migraine, involving almost 2,200 people with migraine. We're really excited that these new six-month data provide further evidence of the potential benefit AMG 334 could provide to people living with the debilitating symptoms of this disease."

Patients enrolled in STRIVE were randomised to receive either placebo, or one of two AMG 334 doses, 70mg or 140mg, subcutaneously, once monthly, for six months.

Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline.

Over the last three months of the double-blind treatment phase, patients in the 70mg and 140mg AMG 334 treatment arms experienced a statistically significant 3.2-day and 3.7-day reduction from baseline in mean monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.

The safety profile of AMG 334 was comparable to placebo across both treatment arms over the six-month double-blind evaluation.

The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and sinusitis.