Novartis/Amgen's migraine drug hits market at lower than expected price

Novartis/Amgen's migraine drug hits market at lower than expected price

A new medicine that is created to prevent the onset of a migraine was approved by the Food and Drug Administration on Thursday. It blocks the molecule that transmits the migraine pain signals, known as calcitonin gene-related peptide (CGRP).

On Thursday, the USA regulators approved the use of first drug, Aimovig, which has been designed as a preventive treatment for chronic migraines in people.

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.

Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide. The drug, which is indicated for once-monthly use, will be available to patients in both a 70 mg and 140 mg self-administered auto-injector within 1 week of the approval. In a dedicated study with patients with difficult-to-treat conditions - like those with episodic migraine who have failed two to four prior treatments - a dose of Aimovig 140 mg resulted in an nearly tripling of the chance of reducing their migraine days by half compared to a placebo.

The second three-month trial included 577 episodic migraine patients, where patients experienced on average one fewer migraine day per month than those on placebo.

Amgen Inc is also in collaboration with the Swiss pharmaceutical firm Novartis that can help in commercializing the medication rapidly and across the globe.

The approval for sale in the European Union is expected in the next few months.

Erenumab consistently demonstrated an ability to reduce monthly migraine days in patients with episodic and chronic migraine in 3 major clinical trials, ARISE, STRIVE, and LIBERTY. Compared to a placebo, Aimovig also resulted in a significant reduction in the use of acute migraine medications. Most commonly reported side effects were injection site reactions and constipation. Researchers say CGRP plays an important role in migraines.

Aimovig is the first in a new class of treatments created to prevent migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off a migraine, such as dilation of blood vessels in the brain. "Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success".

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