Amgen Migraine Drug Gets FDA Nod, First in New Class of Medicines

Xconomy National — 

[Updated 5/18/18, 8:38 a.m. See below.] An Amgen migraine drug developed to head off pain before it starts has won FDA approval, the first for a new class of preventive drug candidates for the condition.

The Amgen (NASDAQ: AMGN) drug, erenumab (Aimovig), is a subcutaneous injection given once a month. The drug blocks the receptor for calcitonin gene-related peptide (CGRP), a protein released by neurons that is thought to play a role in the start of migraine pain. In contrast to triptans, an older group of medications that patients take at the onset of pain, these CGRP drugs are meant to stop the activity that leads to migraine symptoms before they escalate into a full-blown attack.

Amgen set a $6,900 annual price for its drug, or $575 a month. The company said late Thursday that the drug will become available within a week.

Because the drug is a preventative medicine for a chronic condition, a patient would need to take the drug on a regular basis, perhaps for life. While physicians and industry observers welcome a new approach to treating migraine, some have expressed concerns about whether the Amgen drug, and the others in its class, will be too expensive.

Amgen’s price comes in below the cost that the Institute for Clinical and Economic Review (ICER), a drug-price watchdog, used in its own analysis of the value of the experimental CGRP-blocking drugs. ICER evaluated these drugs using an $8,500 annual cost that was based on analyst estimates. David Rind, ICER’s chief medical officer, said that at that price, the group’s draft report found that these drugs would be cost effective for patients who have frequent migraines that have not responded to other treatments. Other FDA-approved treatments are available for migraine prevention, though they come with serious side effects.

[Paragraph added with analyst comment.] In a research note, Leerink Partners analyst Geoffrey Porges wrote that Amgen and partner Novartis (NYSE: NVS) “appear to have more or less acquiesced to ICER’s analysis.” But by pricing its drug well below the $8,000 to $10,000 range that Wall Street expected, the companies will benefit by being the first to sell this new type of medicine addressing a large group of patients, he added. Amgen estimates 10 million Americans could benefit from CGRP-blocking drugs, and Leerink’s inquiries indicated that there are already patients who have tried other migraine treatments and are now waiting for the new medicine. Amgen will “benefit significantly from its first mover advantage, and ultimately retain 35-40 percent market share long-term,” Porges wrote.

Migraines affect more than 38 million people in the U.S., and more than 1 billion people worldwide, according to the pharmaceutical industry-funded Migraine Research Foundation. An estimated 90 percent of migraine sufferers have episodic migraine, ranging from five to 14 headaches per month. Between 5 and 8 percent, have chronic migraine, defined as more than 15 headaches per month.

FDA approval of erenumab covers both episodic and chronic migraine. The Amgen drug was studied in three late-stage clinical trials. In the first Phase 3 trial, a six-month study that enrolled 955 episodic migraine patients, those given erenumab experienced an average 50 percent reduction in the number of days they had migraine headaches compared to those who took a placebo. Side effects included inflammation of the nasal passages and upper respiratory tract infections. The most common side effects reported were reactions at the site of the injection and constipation. In a Phase 3b study in patients with difficult to treat cases—episodic migraine that had failed to respond to as many as four earlier treatments—Amgen reported that patients treated with its drug were three times more likely to have their headache days per month cut by half or more compared to those given a placebo.

With FDA approval in hand, the Amgen drug will be the first CGRP-targeting medicine to reach the market. Other drugs that work in a similar way could soon follow. The Eli Lilly (NYSE: LLY) drug galcanezumab, also a monthly subcutaneous injection, is expected to receive an FDA decision in the third quarter of this year. The FDA was scheduled to issue a decision in June for the Teva Pharmaceutical (NYSE: TEVA) drug fremanezumab, a drug injected once every three months. But that drug faces a likely delay due to problems that the FDA found with a third-party manufacturer that Teva uses to make the product.

A fourth migraine-preventing drug, eptimezumab, has completed late-stage testing for both episodic and chronic migraines. Its developer, Bothell, WA-based Alder BioPharmaceuticals (NASDAQ: ALDR), plans to file for FDA approval early next year.

The Amgen drug’s late-stage clinical development was financed in part by Novartis. In 2015, when the drug was about to start Phase 3 testing, Novartis licensed rights to the compound outside of the U.S. and Japan. The deal also included rights to other migraine drugs in Amgen’s pipeline. In exchange, Novartis agreed to finance additional R&D for erenumab, and to pay royalties on sales of the drug if it reached the market. In addition to its review by the FDA, the drug is currently being evaluated by regulators in Europe.

Last year, Amgen and Novartis entered into a partnership to sell erenumab. The companies will work together to sell the drug in the U.S. Amgen keeps rights to the drug in Japan, while Novartis holds drug marketing rights in the rest of the world. If the drug hits development and regulatory targets, Amgen stands to gain more than $400 million in milestone payments from Novartis.

Photo by Amgen