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Lilly Gets FDA Approval for New Oral Tablets for Migraine

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Eli Lilly & Company (LLY - Free Report) announced that the FDA has approved lasmiditan for the treatment of acute migraine headaches, with or without aura, in adults. Lasmiditan, an oral 5-HT1F agonist, is the first and only FDA-approved medicine in this class of migraine drugs. Lasmiditan will be marketed by the trade name of Reyvow and will be available in oral doses of 50 mg, 100 mg, and 200 mg, once launched.

The new drug application for Reyvow was based on data from two phase III studies, SAMURAI and SPARTAN. Both the studies met the efficacy endpoints. Data from the studies showed that treatment with Reyvow led to pain freedom and freedom from most bothersome symptoms of migraine at two hours after administration of Reyvow compared to placebo.

Please note that lasmiditan was added to Lilly’s portfolio with the 2017 acquisition of CoLucid Pharmaceuticals.

Year to date, Lilly’s shares have declined 6.3% compared with the industry’s decrease of 0.8%.



Reyvow’s approval has boosted Lilly’s portfolio of pain medicines, which also includes recently launched, Emgality, its CGRP antibody, for the preventive treatment of migraine.  Emgality was launched in the United States in September last year. Emgality was approved in the United States for another indication, episodic cluster headache in June 2019. Emgality, a once-monthly, self-administered, subcutaneous 120 mg injection, could emerge as a significant contributor to long-term growth at Lilly. However, it faces strong competition from Teva (TEVA - Free Report) and Amgen’s (AMGN - Free Report) CGRPs, Ajovy and Aimovig, respectively, which were also approved in 2018.

Lilly’s pain portfolio also includes tanezumab, which is being evaluated, in collaboration with Pfizer, Inc. (PFE - Free Report) . Lilly expects to file a NDA for tanezumab for treating osteoarthritis pain next year.

Lilly currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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