Lundbeck, a Danish pharmaceutical company, has secured approval from the US Food and Drug Administration (FDA) for its Vyepti as a preventive treatment for migraine in adult patients.
Claimed to be the first FDA-approved intravenous (IV) treatment for migraine prevention, the Vyepti will be available from April and the recommended dose is 100mg for every three months.
Vyepti is a humanised monoclonal antibody, which attaches to calcitonin gene-related peptide (CGRP) ligand and restricts its binding to the receptor.
Vyepti’s efficacy and safety were evaluated in two phase III clinical trials, including PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine.
Lundbeck assessed the efficacy of Vyepti as a preventive treatment of episodic and chronic migraine in two randomised, placebo-controlled studies, both with a six-month double-blind period.
Vyepti was assessed in 2,076 patients with migraine who received at least one dose of the treatment. Both studies did not include patients with a history of cardiovascular disease, neurological disease, and cerebrovascular disease.
The change from baseline in mean monthly migraine days (MMD) over months 1-3 is the primary endpoint, which was achieved by Vyepti.
The Danish pharmaceutical firm has also an application for market authorisation of Vyepti in Canada, as well as plans are underway to file an application in the European Union during 2020.
It will be followed by the submission of applications in other regions and countries across the world, including China and Japan.
Lundbeck president and CEO Dr Deborah Dunsire said: “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.”
Alder BioPharmaceuticals is involved in the discovery, development and commercialisation of novel therapeutic antibodies.