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Amgen/Novartis potential blockbuster migraine med gets FDA nod

Published on 18/05/18 at 09:35am

The first in a new class of migraine treatments has just received approval from the FDA; Amgen and Novartis’ Aimovig is the first CGRP inhibitor to receive approval but won’t be the last, as a number of competitors wait in the wings.

The first-to-market status the drug has achieved allowed Amgen to carefully consider the pricing of the drug in the US market and it has aired on the conservative side.

Though that may seem odd for a treatment costing $6,900 per year, it is below the $10,000 price point that some analysts predicted Amgen would enter the treatment at.

It seems likely that the company has learnt its lesson from its pricing of Repatha, after it was widely rejected by payers for being too expensive as a treatment for reducing high LDL cholesterol at an initial price of $14,000 per year.

Amgen will be hoping that its pricing method is enough to persuade payers that the treatment is worth it and, with only repurposed drugs available for migraine sufferers, it does manage to achieve the industry’s favourite catchphrase of meeting ‘unmet medical need’.

“Migraine is a serious neurological disease that has dramatic effects on patients' lives. Migraine patients experience excruciating headache pain, often accompanied by other symptoms such as nausea and vomiting, and many live in constant dread of the next attack,” said Sean E. Harper, Executive Vice President of R&D at Amgen. ”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.”

The treatment will administered by the patients themselves through monthly self-injectors, which the companies have already talked up as being likely to make patients more adherent than having to take daily pills.

This will have been said knowing that Allergan’s oral CGRP inhibitor, ubrogepant, an oral form of the medication, is likely not far away from receiving its own approval and becoming a direct competitor.

Besides Allergan, Eli Lilly is also seeking approval for its treatment, alongside alternatives being developed by Teva and Alder.

Novartis and Amgen’s product is expected to become a blockbuster treatment but much will depend on how successfully their competitors enter the market, and how they react to the pricing question.

Ben Hargreaves

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