After 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 also recently recommended for approval by the EMA's Human Medicines Committee; availability in pharmacies is still open.

The three antibodies aim to inhibit the action of calcitonin gene related peptide (CGRP). Galcanezumab was approved in Europe in November 2018 and will now be available in pharmacies in Germany from April 1, 2019. Approval for fremanezumab in Europe is currently pending, but it has already been recommended by the Committee for Medicinal Products for Human Use. Due to deficiencies at the Korean drug manufacturer Celltrion, the USA approval of fremanezumab by the FDA was delayed.

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

Similar to erenumab, galcanezumab is administered by patients themselves through a subcutaneous injection using an autoinjector. Initially, a so-called loading dose of 240 mg is administered. A further injection of 120 mg is then given every 1 month. Monthly treatment is for erenumab (70 mg) and fremanezumab (225 mg). In contrast, fremanezumab can also be administered quarterly, for which an active ingredient amount of 625 mg is approved. However, there is no auto-injector that provides this total amount of active ingredient. Rather, for this form of application, patients must administer 3 injections of 225 mg fremanezumab each.

Galcanezumab was studied in 3 large phase 3 trials, Evolve 1, Evolve 2 and Regain. The main finding in the Evolve 1 study with 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 when a dummy preparation was administered.

In Evolve 2, when 915 patients were included, 59.3% of patients treated with galcanezumab halved their monthly headache days with galcanezumab. The administration of placebo resulted in halving the number of headache days per month in 36%. On average, the patients who received 120 mg of galcanezumab experienced 4.3 fewer migraine days per month; those who received placebo experienced a reduction of 2.3 fewer days per month. The baseline in the group treated with galcanezumab was 9.1 migraine days per month and in the placebo group 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.

The drug Emgality is available as a pre-filled pen. The pack sizes each contain 2 or 3 auto-injectors. Patients can use this auto-injector to inject the medication subcutaneously on their own. The medication can be administered under the skin on the stomach, thigh, upper arm, or buttock area.

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:// painklinik.de/wp-content/uploads/2019/03/emgality-galcanezumab-properties.pdf

https://youtu.be/UQfER7Ev0-0