Lilly bags FDA approval for migraine drug; may give it for free to insured patients

By PharmaCompass

2018-10-04

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Until May this year, there weren't any drugs available for alleviating migraines. Since then, patients who suffer from migraine have seen three new migraine-specific treatments approved by the FDA.

The latest drug to get the FDA approval is Eli Lilly’s Emgality (galcanezumab-gnlm) injection for migraine prevention. Like its competitors, Lilly is offering it at little or no cost to the insured patients in the US for a limited period.

The day Lilly bagged the FDA approval, a federal judge also dismissed two patent infringement lawsuits by Teva Pharmaceutical Industries against Lilly related to Emgality. The drug is also on track for final approval in the European Union.

Galcanezunab is a CGRP (short for calcitonin gene-related peptide) inhibitor, a molecule that researchers have been targeting since the 1980s. A drug from Amgen approved in May and another from Teva approved earlier in September work on the same principle. All three approved migraine drugs require delivery by injection, though Allergan is working on pills that would deliver similar migraine-fighting compounds for preventative and acute treatment.

Emgality will have a list price of US$ 6,900 a year, which is in the same price range as its competitors from Amgen and Teva.

According to the Migraine Research Foundation, migraines affect around 39 million Americans, with 4 million Americans suffering daily symptoms. According to data compiled by Bloomberg, Emgality is forecast to sell US$ 701 million in 2022. And CGRP drugs are expected to become a US$ 2.2 billion market in the US, Bloomberg Intelligence estimates.

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