An Eli Lilly migraine drug that was approved last fall now has the regulatory nod to treat a rarer form of headache that tends to occur in clusters.
The FDA on Tuesday approved the Lilly (NYSE: LLY) drug galcanezumab (Emgality) for episodic cluster headaches, which patients experience as one to four headaches per day, each one lasting between 15 minutes and two hours. The cause of cluster headaches is not known, and they have no cure. The current standard of treatment includes triptans, an older class of drugs that treat migraine pain after it starts.
Galcanezumab is part of a new class of injectable migraine drugs developed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain. These drugs don’t stop migraine attacks entirely, but clinical testing has shown that they can reduce their frequency by as much as 50 percent in some patients.
Besides Lilly, other companies that have won FDA approval for CGRP inhibitors are Amgen (NASDAQ: AMGN) and Teva Pharmaceutical (NYSE: TEVA). Alder BioPharmaceuticals (NASDAQ: ALDR) is awaiting an FDA decision on its CGRP drug.
These CGRP drug developers have been trying to expand the use of their therapies to other types of headaches. Teva’s efforts have fallen short, failing in clinical trials for both chronic and episodic cluster headache.
The FDA approval of Lilly’s galcanezumab in episodic cluster headache is based on a clinical trial that tested the drug in 106 patients for three weeks. During that period, the FDA said that patients taking the drug experienced an average of 8.7 fewer weekly cluster headache attacks than they did at the start of the trial. Patients given a placebo experienced 5.2 fewer headache attacks on average. The most common side effect reported in the study was a reaction at the site of the injection.
Galcanezumab, which is available as a self-injected drug, is sold at a list price of $575 monthly, or $6,900 annually, though a patient’s out-of-pocket cost varies by insurance plan. Lilly has not yet announced galcanezumab’s price for chronic cluster headache.