Lilly pushes into migraine market as Emgality approved in US

The FDA has approved Eli Lilly’s Emgality (galcanezumab) for migraine prevention in adults, the third in a group of new class of drugs for the condition.

Calcitonin gene-related peptide (CGRP) class drugs are the first that are specifically approved to treat migraine, which had previously been tackled with unapproved therapies such as Botox and anti-seizure medication.

Teva’s CGRP drug Ajovy (fremanezumab) was approved by the FDA earlier this month, while Novartis and Amgen’s Aimovig (erenumab) got approval in May.

That leaves only Alder BioPharmaceuticals, which is developing eptinezumab in phase 3 trials and is yet to file its drug.

Emgality is available as a once-monthly, self-administered, subcutaneous injection, like Aimovig. Teva offers the option of a quarterly injection with Ajovy, as well as a monthly dosing schedule.

Between them the drugs are expected to bring in billions of dollars in revenue for the pharma companies, although eptinezumab may not make such an impact as it is being developed as a drug administered in clinics and hospitals.

Lilly said that the drug will be available at no cost to commercially insured patients, while the company arranges reimbursement deals with payers in the US.

The list price for Emgality will be the same as the rivals from Amgen/Novartis and Teva, who are charging $6,900 a year for their drugs.

Amgen has been giving out two months of free samples, followed by a patient assistance programme providing a year of coverage if commercial insurance does not provide cover.

Teva has offered a savings card that lets patients get Ajovy for free until December next year, Bloomberg reported.

[caption id="attachment_27023" align="alignnone" width="107"] Christi Shaw[/caption]

Christi Shaw, president of Lilly Bio-Medicines, said: "Despite the devastating impact of migraine, only about 10% of people living with the disease are currently taking a preventive treatment.

"For more than two decades, Lilly has recognized this unmet need, and we have worked tirelessly to develop a new option specifically designed for the prevention of migraine. With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease."

The efficacy and safety of Emgality was demonstrated in two phase III clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one phase III clinical trial in patients with chronic migraine (REGAIN).