U.S. FDA approves Lilly migraine drug; price same as rivals

[September 28, 2018]  By Michael Erman

NEW YORK (Reuters) - Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration approved its migraine drug Emgality, marking the third approval from a promising new class of treatments for the often debilitating headaches.

Lilly said it plans to sell the drug, known chemically as galcanezumab, at a list price of $6,900 a year, or $575 month. That is identical to the list prices for the other new migraine treatments, Aimovig from Amgen Inc and Novartis AG, and Teva Pharmaceutical Industries Ltd's Ajovy.

The three medicines, most commonly administered as monthly self-injections, belong to a class of biotech drugs known as CGRP inhibitors that block a protein involved in setting off migraines. CGRP, or calcitonin gene-related peptide, is believed to be involved in the migraine process, such as dilation of blood vessels in the brain.

Around 39 million Americans suffer from migraine headaches, according to the Migraine Research Foundation. Migraines can cause intense pain, nausea and sensitivity to light and sounds, severely disrupting the ability to work or function.

Prior migraine treatments are mostly repurposed generic drugs, including anti-depressants and hypertension medicines, or are medicines that cause nausea and other adverse side effects. Allergan's anti-wrinkle injection Botox is approved for patients suffering from 15 or more migraine headaches a month.

Aimovig become the first CGRP inhibitor to launch, after receiving U.S. approval in May. Early demand for Aimovig has been strong, buoyed in part by Amgen programs giving patients two months of free samples followed by up to a year's supply of the drug for those having trouble with insurance coverage.

Lilly said it plans to launch a similar program that would allow commercially insured patients to receive up to 12 months of Emgality at no cost to the patient.

Lilly said it is in late-stage discussions with the top four or five U.S. health insurers and pharmacy benefit managers with the aim having the drug covered as widely as possible. Those include negotiations around rebates and discounts off the list price.

The talks also include potential value-based payment models, which would allow employers and insurers to reclaim some money if the drug is not effective for a patient, Lilly said.

The company said it expects to begin shipping the drug very soon after approval.

(Reporting by Michael Erman in New York and Aakash Jagadeesh Babu in Bengaluru; Editing by Bill Berkrot and Leslie Adler)

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