AJOVY (fremanezumab) - Migraine

The clinical benefit of AJOVY (fremanezumab) remains substantial in adults with severe migraine who have at least 8 migraine days per month, with previous failure to at least two prophylactic treatments and without cardiovascular impairment (patients having had clinically significant cardiovascular disease or vascular ischaemia, or thromboembolic events).

Considering:

• initial efficacy data having demonstrated the superiority of fremanezumab compared to placebo with a moderate effect size on the change in the monthly number of migraine days in episodic and chronic migraine, including one study (FOCUS) specifically in patients with previous failure to 2 to 4 prophylactic treatments, and mostly with at least 8 migraine days per month,
• new efficacy data from interim analyses of observational studies without a control group, and their limitations, particularly in terms of transposability (in particular, analysis restriction, incomplete information on previous prophylactic treatments received, absence of French centres, etc.),
• the absence of robust new comparative efficacy data versus an active comparator in a context of failure to at least 2 prophylactic treatments, despite this comparison being feasible,
• the absence of comparative quality of life data versus an active comparator for the total population eligible for treatment,
• and despite the medical need in this population,

the Committee considers that AJOVY (fremanezumab) provides no clinical added value (CAV V) in the care pathway for the prophylactic treatment of adults with severe migraine who have at least 8 migraine days per month, with previous failure to at least two prophylactic treatments and without cardiovascular impairment (patients having had clinically significant cardiovascular disease or vascular ischaemia, or thromboembolic events).