Amgen (NSDQ:AMGN) won FDA approval this week for its once-monthly Aimovig injection designed to prevent the onset of migraines in adults.
The drug is the first of its kind – a molecule that blocks the receptor for a protein that is linked to migraine pain, the calcitronin gene-related peptide. Other major pharmaceutical companies like Eli Lilly (NYSE:LLY) and Teva Pharmaceuticals (NYSE:TEVA) are working on their own CGRP product, but Amgen’s is the first to hit the market.
Migraines aren’t just headaches – the condition is marked by focused, throbbing pain that can render people sensitive to light and sound. It affects more than 10% of people worldwide, according to the FDA, and nearly 38 million in the U.S. alone.
Amgen’s subcutaneous injection is delivered using the company’s SureClick auto-injector and priced at $6,900 per year. The pricetag fell below analysts estimates. The Institute for Clinical & Economic Review pegged the product’s annual price at $8,500.
In a 12-week Phase III trial, Amgen enrolled 246 people with episodic migraine who previously failed treatment. The study met its primary endpoint, which was the proportion of patients with at least 50% reduction of monthly migraine days after four weeks of treatment.
Aimovig is slated to be available for patients within one week.
“The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine,” Dr. Sean Harper, EVP of R&D at Amgen, said in prepared remarks.
A “very promising development”
For patients that are seeking preventive treatment for migraines, there are other options on the market – but they’re all drugs that were never specifically developed for that indication. For instance, some patients use a blood pressure drug that incidentally helps to prevent migraines.
But these drugs are not very effective, according to neurologist Dr. Egilius Spierings of Tufts University, and they have an array of side effects like exhaustion and weight gain.
Spierings has practiced for more than four decades and he described Amgen’s latest regulatory win as a “very promising development” for patients.
He has treated close to 250 patients across the four CGRP-antibodies in development, he told Drug Delivery Business News, and has been amazed by the medicine’s tolerability.
“I have never worked with a class of medicines this well-tolerated and this effective,” Spierings said.
CGRP-antibodies have been “life-changing” for many of Spierings’ patients. He has been involved in CGRP trials since 2012 and in just six years, the first CGRP-antibody is ready for prime-time.
“I believe this is going to change the face of migraine management all-together,” Spierings said.
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