Following erenumab (Aimovig®) on November 1, 2018, the second antibody, galcanezumab (Emgality®), for migraine prophylaxis will also be available in Germany on April 1, 2019. Galcanezumab has been approved in the EU since November 2018. The third antibody, fremanezumab (Ajovy®), was recently recommended for approval by the EMA's Committee for Medicinal Products for Human Use (CHMP); its availability in pharmacies is still pending.

The three antibodies target the inhibition of the action of calcitonin gene-related peptide (CGRP). Galcanezumab was approved in Europe in November 2018 and is expected to be available in German pharmacies from April 1, 2019. Approval for fremanezumab in Europe is still pending, but it has already been recommended by the Committee for Medicinal Products for Human Use (CHMP). Due to deficiencies at the Korean manufacturer Celltrion, FDA approval of fremanezumab in the US was delayed.

Galcanezumab is approved for the prevention of migraine in adults who experience migraine attacks on at least four days per month. Galcanezumab is a humanized monoclonal antibody. Unlike erenumab, galcanezumab and fremanezumab do not work directly by inhibiting the CGRP receptor. They neutralize the CGRP messenger substance directly.

Similar to erenumab, galcanezumab is self-administered by patients via subcutaneous injection using an autoinjector. An initial loading dose of 240 mg is administered, followed by a further injection of 120 mg every month. This monthly treatment regimen is used for both erenumab (70 mg) and fremanezumab (225 mg). In contrast, fremanezumab can also be administered quarterly, for which a dose of 625 mg is approved. However, there is no autoinjector available that delivers this total dose. Instead, patients must administer three separate 225 mg injections of fremanezumab for this regimen.

Galcanezumab was investigated in three large phase 3 trials: Evolve 1, Evolve 2, and Regain. The main finding in the Evolve 1 trial, which included 858 patients, was that 62.3% of patients were able to halve their monthly headache days by at least 50%. This effect was achieved in 38.6% of patients receiving a placebo.

In the Evolve 2 trial, which included 915 patients, 59.3% of those treated with galcanezumab experienced a halving of their monthly headache days. Placebo resulted in a halving of headache days per month in 36% of patients. On average, patients receiving 120 mg of galcanezumab experienced 4.3 fewer migraine days per month, while those receiving placebo saw a reduction of 2.3 fewer days per month. The baseline average for galcanezumab treatment was 9.1 migraine days per month, and for the placebo group, it was 9.2 migraine days per month.

The Regain study examined patients with chronic migraines. There was a reduction in monthly headache days under galcanezumab by 4.8 days from 19.4 days. When treated with placebo, there was a reduction in headache days per month by 2.7 days, starting from 19.6 days before the start of treatment.

The tolerability of galcanezumab was similar to the tolerability of placebo.

Emgality is supplied as a pre-filled pen. The pack sizes contain either two or three auto-injectors. Patients can use this auto-injector to self-administer the medication subcutaneously. The medication can be administered under the skin in the abdomen, thigh, upper arm, or buttocks.

A detailed summary of the characteristics of galcanezumab can be found in the texts below.

http://ec.europa.eu/health/documents/community-register/2018/20181114142679/anx_142679_de.pdf

https://schmerzklinik.de/wp-content/uploads/2019/03/emgality-galcanezumab-eigenschaften.pdf

https://youtu.be/UQfER7Ev0-0