Novartis, Amgen Get FDA Nod for Migraine Drug

1819 A man suffering from a headache is tormented by a horde of little demons. 'Headache' by Cruikshank

1819 A man suffering from a headache is tormented by a horde of little demons. 'Headache' by Cruikshank

Aimovig works by blocking a protein fragment called CGRP, which instigates and perpetuates migraines.

Amgen (AMGN - Free Report) and partner Novartis (NVS - Free Report) announced that the FDA has approved their pipeline candidate Aimovig (erenumab) for the prevention of migraine.

According to Beatings, a large number of people requires new methods to treat migraine headaches, which is a debilitating condition in which significantly reduced human activity. They are three times more likely in women than in men.

Aimovig 70 mg is self-administered once monthly via Amgen's device, the SureClick autoinjector, and does not require a loading dose. In the first trial (n=955), which included those with a history of episodic migraine, participants experienced, on average, one to two fewer monthly migraine days per month.

Companies including Teva Pharmaceutical Industries, Eli Lilly & Co, and Alder Biopharmaceuticals Inc are developing similar treatments.

Amgen, which will market Aimovig in partnership with Novartis, said the drug's price "reflects the value it brings to patients and society".

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In addition to painkillers and triptans, which ease migraine effects when taken after one starts, preventative treatments for migraines already exist in the form of blood-vessel constrictors and Botox treatments.

In a statement on Thursday, Express Scripts said migraine patients have a serious unmet need, but "not everyone will need this drug" and it will have a program in place to make sure the medication is authorized for only the appropriate patients. However, earlier this month, Teva informed that it does not expect to get FDA approval for fremanezumab on its PDUFA date in June.

During the phase 2 and phase 3 clinical trials in patients with chronic and episodic migraine, the use of Aimovig resulted in significant decline in monthly migraine days.

Injection site reactions and constipation were the most common adverse reactions in clinical studies of Aimovig. "Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine". If approved, the drugs are expected to cost US$8,500 per year.

Aimovig is the first in a new class of treatments created to prevent a migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off the severe headaches, such as dilation of blood vessels in the brain.

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