A migraine drug that Lundbeck added to its pipeline via its nearly $2 billion acquisition of Alder BioPharmaceuticals won FDA approval on Friday.
The drug, eptinezumab (Vyepti), is part of a new class of antibody therapies developed to prevent migraine attacks before they start. These drugs block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain. The first three drugs from this class that won FDA approval for migraine prevention are injectable therapies. The Lundbeck drug is given as an intravenous infusion, the first CGRP drug approved in this formulation.
Before CGRP drugs hit the market in 2018, the migraine-prevention treatments available to patients were older drugs initially approved for other conditions, such as anti-seizure medications and Botox injections. CGRP inhibitors became the first new drugs approved specifically for migraine prevention. The Amgen drug (NASDAQ: AMGN) erenumab (Aimovig) was the first CGRP drug to win FDA approval, followed by Eli Lilly (NYSE: LLY). Both are taken once a month via subcutaneous injections that patients can give themselves. Teva Pharmaceutical (NYSE: TEVA) markets its CGRP drug in once a month or once every three month doses that patients can inject themselves.
Eptinezumab was originally discovered by Alder, a Bothell, WA-based biotechnology company. As an IV formulation, the drug must be administered by clinicians in a healthcare facility. But Alder has said that its therapy is intended to take effect more quickly and last longer. The drug is administered once every three months.
When Copenhagen, Denmark-based Lundbeck acquired Alder last fall, CEO Deborah Dunsire told Xconomy that she thinks the drug has “blockbuster growth potential.” But in addition to competing against CGRP drugs from Amgen, Lilly, and Teva, Lundbeck must compete against the older, less expensive migraine-prevention therapies. Lundbeck has not yet disclosed a price for its migraine drug, but after Teva and Lilly won approval for their respective CGRP drugs, they priced them in line with the wholesale price Amgen set for its drug of $575 per month.
The FDA’s eptinezumab decision was based on data from two Phase 3 studies, one enrolling patients with episodic migraine (four to 14 headache days per month) and the other enrolling patients with chronic migraine (15 to 26 headache days per month). Patients were randomly assigned to receive either a 100 mg dose of eptinezumab, a 300 mg dose, or a placebo. The main goal of both studies was a change from baseline in average migraine days per month from months one to three of the study. Patients were allowed to use drugs for acute migraine treatment during the clinical trial.
In the episodic migraine study, the average reduction in monthly migraine days was 3.9 days in the 100 mg group; 4.3 days in the 300 mg dose group. The average reduction was 3.2 days in the placebo group. In the chronic migraine study, the average reduction in monthly migraine days was 7.7 days in the 100 mg group; 8.2 days in the 300 mg group; and 5.6 days in the placebo group.
The most common side effects observed in the studies were swelling in the nasal passages and back of the throat, and hypersensitivity. The drug’s label warns that reactions to the drug include angioedema, which is swelling that can affect the face, abdomen, or limbs. Most such reactions occurred during infusion and were not serious. But when they did occur, patients often stopped taking the drug or required treatment for those reactions.
Lundbeck says eptinezumab will become available in the US in April. The company has applied for approval in Canada and plans to file for approval in Europe later this year. Lundbeck also plans to submit regulatory applications in other markets, including China and Japan.