FDA approves first and only IV preventive treatment for migraine

Danish CNS specialist Lundbeck (LUND: CO) late on Friday revealed that Vyepti (eptinezumab-jjmr) has been approved by the US Food and Drug Administration for the preventive treatment of migraine in adults and will be available in April 2020. Vyepti is the first FDA-approved intravenous (IV) treatment for migraine prevention.

Lundbeck acquired rights to the drug along with its $1.95 billion purchase of US drug developer Alder BioPharmaceuticals last fall. Alder is also developing ALD1910, a monoclonal antibody (MAb) designed to inhibit pituitary adenylate cyclase-activating polypeptide for migraine prevention.

Dr Deborah Dunsire, president and chief executive of Lundbeck, commented: “With the approval of Vyepti, I am pleased that we are now able to offer a new IV therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy. The Vyepti clinical program is the first to demonstrate this early benefit.”