Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial

RCT (n=462) found that galcanezumab-treated patients had greater reduction in migraine headache days vs. placebo across months 1–3 (on average 4.1 fewer monthly migraine headache days than at baseline (13.4), compared with 1.0 fewer than at baseline (13.0) with placebo (p<0.0001)

SPS commentary:

In February, the European CHMP did not recommend approval of galcanezumab, a monoclonal antibody that selectively binds to and inhibits the activity of calcitonin gene-related peptide, for prevention of attacks of episodic cluster headache. The Committee was of the opinion that the results from the main study in the application did not show clearly that galcanezumab is effective for preventing attacks.

The Lancet Neurology