Nordic Life Science 1
BUSINE S S D E A L ALDER IS DEVELOPING eptinezuma
b for the preventive treatment of migraine in adults. If approved by the FDA it will be the first IV CGRP therapy for migraine prevention. Alder is also developing ALD1910, a mAb designed to inhibit pituitary adenylate cyclase-activating polypeptide for migraine prevention. Alder submitted a Biologics License Application to the FDA for eptinezumab in February 2019 and the FDA has set a Prescription Drug User Fee Act action date of 21 February 2020. “Alder is an excellent strategic fit for Lundbeck’s focused expertise in brain diseases and organizational capabilities. Migraine prevention is an attractive indication for us that leverages our specialized commercial expertise in delivering medicines for brain diseases,” says Deborah Dunsire, CEO, Lundbeck. Lundbeck expects to submit eptinezumab for approval to regulatory authorities in the European Union during 2020, followed by submissions for approval in other regions around the world including China and Japan. Deborah Dunsire, CEO, Lundbeck