FDA approves Emgality for preventive treatment of migraine.- Eli Lilly
Eli Lilly and Company announced that the FDA has approved Emgality (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults. Emgality offers a once-monthly, self-administered, subcutaneous injection. Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Emgality will be available to patients shortly after approval. Patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program (governmental beneficiaries excluded; subject to terms and conditions). Emgality will be available for pickup at retail pharmacies.
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).
Comment; Lilly has priced Emgality at a wholesale cost of $6,900 per year, matching the prices set by competitors Amgen and Teva.
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