|Other names||AMG-334, erenumab-aooe|
|Elimination half-life||28 days|
|Chemical and physical data|
|Molar mass||145871.98 g·mol−1|
Erenumab was approved in May 2018 and was the first of a group of four CGRPR antagonists to be approved by the U.S. Food and Drug Administration (FDA) that year. 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.
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.
Mechanism of action
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.
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 (0-mg) group.
Society and culture
The United States Food and Drug Administration (FDA) approved the medication for the preventive treatment of migraine in adults on May 17, 2018. It was the first of four CGRPR antagonists to be approved that year. The list price was reported to be US$6,900 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.
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