Introduction

Galcanezumab (trade name: Emgality) has been approved in Germany since November 2018 for the prevention of migraine. It is an option for adults who have migraine attacks on at least four days a month.

Migraine attacks start suddenly with severe pain on one side of your head. They are much worse than normal headaches and are described as throbbing or pounding. Migraine attacks are usually accompanied by additional symptoms such as nausea, vomiting or sensitivity to light and noise. Left untreated, the symptoms last between 4 hours and 3 days. Migraine can greatly affect everyday life. Then doctors often prescribe medication to manage the symptoms.

Galcanezumab is an antibody. It inhibits the effect of a certain protein (calcitonin gene-related peptide, CGRP) that plays a role in triggering migraine attacks. This aims to prevent attacks.

Application

Galcanezumab comes in a ready-to-use pen with which you inject the medication under the skin (subcutaneously). One pen contains 120 mg of galcanezumab. Treatment is started with one 240 mg dose of the medication, which is equivalent to two ready-to-use pens. After that, treatment continues with one injection (120 mg) per month. If the symptoms have not improved after three months, stopping treatment should be considered.

Other treatments

For patients who haven't had treatment before, as well as those who didn't tolerate or didn't benefit enough from at least one preventive treatment, the treatment options include the drugs metoprolol, propranolol, flunarizine, topiramate and amitriptyline – depending on which drug was used before.

If these drugs aren't effective or can't be used, further options are valproate sodium or clostridium botulinum toxin type A.

If none of the preventive treatments is suitable, best supportive care (BSC) is an option. This treatment should be tailored to the patient's individual needs, with the aim of relieving symptoms and improving quality of life.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of galcanezumab when compared with standard treatments for migraine in adults.

The manufacturer provided studies involving people who had tried at least two treatments without success. The researchers analyzed the data from a total of 218 people from three studies. These studies involved a total of 70 people who had treatment with galcanezumab and 148 people who were given a placebo. Both groups also received best supportive care and had treatment for 3 to 6 months, depending on the study. Patients in two of the studies had migraines for an average of about 9 days a month, while patients in the third study had migraines for about 20 days a month. The study showed the following results in these patients: 

What are the advantages of galcanezumab?

Migraine days per month: The studies suggest that galcanezumab has an advantage here. After starting treatment with galcanezumab, the number of migraine days decreased by half or more in about 51 out of 100 people. This was the case in only about 12 out of 100 people who received a placebo.

In terms of improvement of migraine symptoms, the studies also suggest that galcanezumab has an advantage compared with a placebo.

What are the disadvantages of galcanezumab?

Galcanezumab wasn’t found to have any disadvantages compared with the placebo.

No difference

There was no difference between the treatments in terms of the following aspects:

  • Severity of migraine
  •  Severe side effects
  •  Treatment stopped due to side effects

Health-related quality of life: No relevant difference was found between galcanezumab and the placebo in terms of everyday and social activities, work, concentration, as well as negative effects of migraine on mood.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of galcanezumab (Emgality).