Stellar results for Novartis, Teva anti-CGRP migraine drugs

Fifty percent of patients taking Novartis’ erenumab in a Phase III clinical trial had their migraine days cut by at least half, according to the data.

The six-month Phase III STRIVE study assessed the potential of erenumab - which is designed to specifically block the CGRP receptor - in preventing episodic migraine.

The findings show that the drug delivered "clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints", including those measured by the novel, validated Migraine Physical Function Impact Diary (MPFID), Novartis noted.

Patients taking erenumab at the higher dose experienced a significant 3.7-day reduction in monthly migraine days from the baseline of 8.3 days, compared to 1.8-day reduction with placebo.

MPFID scores in physical impairment, such as getting out of bed or activities requiring physical effort, were also significantly reduced with erenumab (4.8 points versus 2.4 points for placebo).

"STRIVE is the first fully reported Phase III study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine," said principal trial investigator Peter Goadsby, NIHR-Wellcome Trust King's Clinical Research Facility and Professor of Neurology at King's College Hospital, London.

The results "represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy," he added.

The STRIVE study is one of the pivotal trials included in US and EU regulatory applications erenumab, which are currently under review. If approved, Novartis and Amgen will co-commercialise the drug in the US, while Amgen has exclusive rights in Japan and Novartis in rest of world.

Fremanezumab hits targets

Adding further weight to the evidence stacking up in favour of anti-CGRP therapies for migraine, Teva’s fremanezumab also hit its targets in a Phase III study assessing its potential in preventing chronic migraine.

Also published in the NEJM, data from the HALO clinical development programme show that percentage of patients with a reduction of at least 50 percent in the average number of headache days per month was 38 percent in the fremanezumab-quarterly group, 41 percent in the fremanezumab-monthly group, and 18 percent in the placebo group.

The reduction in the average number of headache days per month was around 4.3 with fremanezumab quarterly, 4.6 with monthly dosing, and 2.5 with placebo.

"Results from the Phase III study of fremanezumab for the preventive treatment of chronic migraine highlight the importance of therapies targeting CGRP as a potential significant advancement in the treatment of patients suffering from debilitating symptoms," noted Stephen Silberstein, principal investigator of the HALO trial, Professor of Neurology and Director of the Jefferson Headache Center at Thomas Jefferson University Hospital and lead author of the publication.

The findings were included in the US submission for fremanezumab, which was filed in October.