Amgen Inc. (AMGN, Financial) announced July 20 the U.S. Food and Drug Administration will review its Biologics License Application for Aimovig.Â
Aimovig is the brand name under which erenumab – a monoclonal antibody designed to prevent migraines – will be commercialized when it is approved.
The company says the BLA for Aimovig is supported by data from phase III clinical trials that were conducted on over 2,600 patients who were experiencing more than four days of migraines on a monthly basis.
Amgen says erenumab will target the calcitonin gene-related peptide, or CGRP, receptor.
The CGRP is a product of the splicing of calcitonin- a thyroid hormone - and a powerful vasodilator peptide. The increase of its levels has been associated with migraines.
Aimovig, which has been developed by Amgen, prevents migraines by controlling the levels of CGRP by inhibiting its receptor.
The action date set by the FDAÂ under the Prescription Drug User Fee Act (PDUFA)Â is May 17, 2018.
A migraines is one of the most common forms of headache. It is usually described as an intense and pulsating pain, which tends to slowly rise in the front or on one side of the head. Minor cases may last a few hours, but the most severe cases can span several days. Some patients may complain of other symptoms, including nausea and light sensitivity. Migraines are more common among female patients, but can affect all age groups.
In the U.S., an estimated 6% of men (approximately 19.5 million) and 18% of women (approximately 58.5 million) get migraines on a yearly basis. About 15% of the worldwide population (approximately one billion people) is affected by this form of headache.
Amgen is trading around $179.32 per share with a market capitalization of $131.87 billion, a price-earnings (P/E) ratio of 17.03, a price-book (P/B) ratio of 4.31, a price-sales (P/S) ratio of 5.75 and an EV/EBITDA ratio of 10.55.
The company distributes an annual dividend of $4.60 through quarterly payments of $1.15 per share, for a dividend yield of 2.57% based on the most recent share price.
Disclosure: I have no positions in any stock mentioned in this article.
