A machine generated summary based on the work of Sacco, Simona; Bendtsen, Lars; Ashina, Messoud; Reuter, Uwe; Terwindt, Gisela; Mitsikostas, Dimos- Dimitrios; Martelletti, Paolo. 2019 in The Journal of Headache and Pain.

Erenumab: First Global Approval

DOI: https://doi.org/10.1007/s40265-018-0944-0

Abstract-Summary Amgen and Novartis are developing erenumab (AIMOVIG™, erenumab-aooe)—a fully human monoclonal antibody calcitonin gene-related peptide (CGRP) receptor antagonist—for the prevention of migraine.

Based on these positive results erenumab was recently approved in the US for the preventive treatment of migraine in adults and has received a positive opinion in the EU for the prophylaxis of migraines in adults who have at least 4 migraine days per month.

Extended: These expiry dates do not include any patent term extension or supple- mental protection certificates that may be obtained in the future to extend the pat- ent terms.

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4 Treatment

Introduction Erenumab (AIMOVIG™, erenumab-aooe) is a fully human monoclonal antibody calcitonin gene-related peptide (CGRP) receptor antagonist being developed by Amgen and Novartis for the prevention of migraine.

In September 2015 Amgen entered into a neuroscience collaboration with Novartis granting the latter global co-development and commercial rights to ere- numab in territories outside of the US, Canada and Japan in exchange for funding disproportional amounts of global R&D expenses for an agreed period and payment of double-digit royalties on sales [156].

This collaboration was expanded in April 2017 giving the two companies co- commercialisation rights to erenumab in the US, and Novartis exclusive commer- cialisation rights in Canada, with Amgen retaining exclusive commercialisation rights in Japan.

Amgen will book sales of erenumab in the US, and will pay a royalty to Novartis

on net sales in the US.

Novartis will book sales in the rest of the world, excluding Japan, and will pay

Amgen royalties on the net sales in those countries.

Scientific Summary In ARISE (A Phase 3, RandomIsed, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334  in Migraine Prevention), patients treated with erenumab 70  mg SC once monthly (n = 282) experienced a least- squares mean reduction from baseline of 2.9 days in monthly migraine days after 3 months compared with a 1.8 day reduction in the placebo group (n = 288; p < 0.001); monthly migraine days at baseline were 8.1 and 8.4 days for erenumab and placebo recipients respectively.

In STRIVE (Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention), erenumab 70 (n = 312) or 140 mg (n = 318) SC monthly reduced the number of migraine days per month by 3.2 and 3.7 days from baseline, respectively, over the final 3 months of double blind treatment (months 4, 5 and 6) compared with a 1.8 day reduction in the placebo group (n = 316; p < 0.001 for both erenumab doses).

Acknowledgement A machine generated summary based on the work of Markham, Anthony. 2018 in Drugs.

Galcanezumab: First Global Approval