Erenumab


Erenumab, sold under the brand name Aimovig, is a medication which targets the calcitonin gene-related peptide receptor for the prevention of migraine. It was the first of the group of CGRPR antagonists to be FDA approved in 2018. It is a form of monoclonal antibody therapy in which antibodies are used to block the receptors for the protein CGRP, thought to play a major role in starting migraines.

Medical uses

Erenumab is indicated for the prevention of migraine in adults.
It is administered by subcutaneous injection.

Side effects

Common side effects are constipation, pruritus, muscle spasms, as well as mild and mostly transient reactions at the injection site.

Interactions

Erenumab was shown not to interact with ethinyl estradiol, norgestimate or the migraine drug sumatriptan. It is expected to generally have a low potential for interactions because it is not metabolized by cytochrome P450 enzymes.

Pharmacology

Mechanism of action

Erenumab is a fully human monoclonal antibody blocking the calcitonin gene-related peptide receptor.

Pharmacokinetics

After subcutaneous injection, the erenumab has an estimated bioavailability of 82%. Highest blood plasma concentrations are reached after four to six days. Like other proteins, the substance is degraded by proteolysis to small peptides and amino acids. It has an elimination half-life of 28 days.

History

Development

Erenumab was developed by Amgen Inc in conjunction with Novartis.
In the phase III STRIVE clinical trial 955 patients were divided into three groups in a 1:1:1 ratio. Each group was injected subcutaneously monthly with 0, 70 or 140 mg erenumab over a period of 6 months. The results were measured as mean monthly migraine days in months 4, 5, and 6. At baseline the patients experienced between 4 and 14 migraine days per month with an average of 8.3. The medication significantly reduced the number of migraine days per month by 3.2 in the 70-mg group and 3.7 in the 140-mg group, versus 1.8 in the placebo group.

Approval and marketing

The United States Food and Drug Administration approved the medication for the preventive treatment of migraine in adults on May 17, 2018. The list price was reported to be per year. It was approved for medical use in the European Union on July 26, 2018.
In the United Kingdom, Erenumab was approved by the Scottish Medicines Consortium, but the National Institute of Health and Care Excellence rejected the drug on the basis that its cost-effectiveness was not sufficiently proven.