Lilly joins CGRP race to cure migraine

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A sad young woman is sitting in her kitchen with a headache

Eli Lilly are gearing up to announce details from the latest Emgality analysis, which can potentially push the biotech to the leading pack of the migraine cure race, among Allergan, Amgen and Novartis.

Emgality, similar to competitive treatments, is a once-monthly, self-administered calcitonin gene-related peptide (CGRP) injection currently under review by the FDA for the prevention of migraine in adults.

The Indianapolis based pharma announced results from a post-hoc analysis which demonstrated efficacy of Emgality in patients with episodic and chronic migraine who had previously failed treatment with Allergan’s BOTOX.

Detailed results from EVOLVE-1, EVOLVE-2 and REGAIN stages of phase 3 studies will be presented tomorrow (SATURDAY 30 June) at the American Headache Society (AHS) annual meeting in San Francisco.

Phase 3 trails included randomised, double-blind, placebo-controlled studies that evaluated the efficacy of single and double doses of Emgality (120 mg and 240 mg) in patients with episodic or chronic migraine.

The results show at least 50% reduction in the number of monthly migraine and headache days in patients who had previously failed BOTOX due to lack of efficacy or tolerability issues.

Christi Shaw, president of Lilly Bio-Medicines, said: "Despite currently available preventive options, nearly half of patients have discontinued these treatments due to side effects or lack of efficacy."

"Over the last two decades, Lilly has recognized and invested in efforts to explore innovative potential treatments for primary headache disorders, including Emgality, which is specifically designed for the prevention of migraine and cluster headache."

Emgality, has been conditionally accepted by the U.S. Food and Drug Administration (FDA) and is expected by the end of September 2018.

CGRP monoclonal antibodies are not new to migraine and headache treatment. Erenumab is in the pipeline of Novartis' research team, while Amgen’s Aimovig has recently been approved by FDA along with its autoinjector.

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Piotr Wnuk

29 June, 2018