FDA approves Amgen migraine drug, price set at $6900 per year

05032015_migraine_headache_wiki

Amgen (AMGN) was first to the finish line late Thursday with a drug created to prevent migraines by blocking a specific receptor - leading Eli Lilly (LLY), Teva Pharmaceutical (TEVA) and Alder Biopharmaceuticals (ALDR).

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

Novartis and Amgen seem to have heeded warnings that healthcare payers may baulk at covering the drug if the price was set too high. Read the back story.

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

The treatment is given by monthly self-injections.

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The drug also fared well on the parameters of efficacy, tolerability and safety during the study which involved more than 3,000 patients. This study did not meet its primary endpoint.

"Having a treatment created to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine", said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School in New Hampshire, in a statement. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials. The company stated that it is working with regulatory agencies around the world to determine the best path forward. This is because Teva's manufacturing partner for fremanezumab, Celltrion, which makes the API, received a warning letter from the FDA this year that delayed the approval of the drug. The company found in two studies that patients on the drug had between a 3.6 and 4-day reduction in migraine days per month (to be eligible, patients had to have between 4 and 14 migraine days per month).

Before the trial, patients had about 18 migraine days. In all instances, participants administered with Aimovig suffered significantly fewer episodes than those on placebos. Aimovig has shown effective results in patients with chronic and episodic migraine problems and has reduced the headache by 99.9% at the first use. The Teva CGRP antibody is now under FDA review for preventive migraine in adults.

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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