US FDA approves Amgen drug for prevention of migraines

  • US FDA approves Amgen drug for prevention of migraines

US FDA approves Amgen drug for prevention of migraines

One in 10 people across the world are afflicted by this ailment.

The drug named, Aimovig is given on a monthly basis by self-injections and will be priced at Dollars 6,900 annually or USD 575 monthly.

Erenumab will cost $575 for a once-monthly dose of 70 mg or 140 mg, or $6900 annually.

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

The high cost of drugs was addressed by President Trump last week.

The FDA has approved the first drug to prevent 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. The FDA noticed that migraine occurs three times more often in women than in men.

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. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy - with a discontinuation rate of 2% percent due to adverse events - and experienced sustained migraine prevention".

The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo.

The most common side effects that patients in the clinical trials reported were injection site reactions and constipation.

"Aimovig provides patients with a novel option for reducing the number of days with migraine", said Eric Bastings, a deputy director in the FDA's Center for Drug Evaluation and Research. "Approximately one-third of affected individuals can predict the onset of a migraine because it is preceded by an aura - transient sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision", the FDA said in its statement.