Lilly Moves Into Migraine Race With CHMP Okay
Executive Summary
Competition is hotting up in the CGRP class of new migraine therapies, with Lilly's Emgality being recommended for approval in Europe, paving the way for a market share battle with Novartis' Aimovig.
Having secured a recommendation for approval in Europe for Emgality (galcanezumab,) and with a green light expected this week from the FDA, Eli Lilly has now caught up with Amgen Inc., Novartis AG and Teva Pharmaceutical Industries Ltd. and their respective calcitonin gene-related peptide (CGRP) blockers for the prevention of migraine.
Emgality is almost certain to be approved in Europe in the next couple of months after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion Sept. 21 for the once-monthly, self-administered injection to be used prophylactically by adults who have at least four migraine days per month. It will probably be the second monoclonal antibody therapy for the prevention of migraine to be authorized for marketing following the approval of Novartis and US partner Amgen's CGRP blocking drug Aimovig (erenumab) at the end of July this year.
The CHMP recommendation is based on three pivotal trials involving 1,780 patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and 1,117 with chronic migraine (REGAIN). After six months of treatment, patients with episodic migraine showed a reduction of 1.9 monthly migraine days on average compared to placebo, while for chronic migraine the reduction was two days.
The most common side effects with Emgality are pain and reactions at the injection site, vertigo and constipation. However, Lilly pointed out that in the Phase III studies, less than 2.5% of patients discontinued due to treatment-related adverse events.
The CHMP green light is the latest development in a busy period on the regulatory front not just for Lilly but for the CGRP space in general. A decision from the FDA on approval for Emgality is scheduled by the end of this month and the agency finally gave the nod Sept. 14 to Teva’s rival migraine product Ajovy (fremanezumab); Aimovig got US approval in May. (Also see "Teva Pushes CGRP Timeline Back To End Of 2018" - Scrip, 3 May, 2018.)
It looks likely there will be three CGRP blockers on the market in the US by next month, where Aimovig and Ajovy carry the same wholesale acquisition cost of $6,900 per year. However, Lilly will probably be taking on just Novartis' Aimovig for a while in the European Union where, the EMA estimates, about 15% of the population suffers from migraines, and where the pricing issue is much more pronounced.
According to a recent Datamonitor Healthcare report, Europe has around 67 million prevalent cases of migraine per year, whereas north America has a lower prevalence proportion and around 27 million prevalent cases per year.
Datamonitor Healthcare’s Pharmavitae analysis predicts that the five largest European markets (Germany, France, UK, Italy and Spain) will account for 37% of Emgality’s peak sales of $2.7bn in 2027 at around $1bn, just behind US sales of $1.1bn. This compares with a Pharmavitae forecast of total 2027 sales of $2.9bn for Aimovig with $884m being booked by Novartis in the five major European markets; and total peak sales of $2.3bn for Ajovy, including $824m in the five major European markets.