Eli Lilly & Company (LLY - Free Report) announced that it has filed a new drug application with the FDA for approval of its migraine candidate, lasmiditan.
The NDA seeks approval of the oral 5-HT1F agonist for the treatment of acute migraine headaches – a medical condition that affects more than 30 million adults in the United States alone. Lasmiditan was added to Lilly’s portfolio with the 2015 acquisition of CoLucid Pharmaceuticals.
Year to date, Lilly’s shares have risen 30% compared with the industry’s increase of 7.6%.
Lilly also said that by the end of the year, it plans to submit a supplemental biologics license application (sBLA) to the FDA for label expansion of its newly approved migraine drug Emgality (galcanezumab) for preventive treatment of episodic cluster headache. Lilly gained FDA approval for Emgality, its CGRP antibody, for the preventive treatment of migraine in adults in late September. Lilly also said that the FDA has granted Breakthrough Therapy status to Emgality for the episodic cluster headache indication.
The designation from the regulatory body is intended to expedite the development and review of drugs with early evidence of substantial potential clinical benefit to patients, or benefit patients without current treatment options. At present, no medicines are approved for preventive treatment for episodic cluster headache in the United States.
Data from a late-stage study evaluating Emgality for the prevention of episodic cluster headache in May showed that the drug (300 mg once-monthly) led to statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month treatment period — the primary endpoint. At week 3, a statistically significantly greater percentage of patients in the Emgality arm achieved at least 50% reduction in weekly cluster headache attacks (secondary endpoint) compared to placebo.
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’s (TEVA - Free Report) and Amgen’s (AMGN - Free Report) CGRPs, Ajovy and Aimovig, respectively, which were also approved this year.
Lilly’s pain portfolio also includes tanezumab, being evaluated, in collaboration with Pfizer, Inc. (PFE - Free Report) , for multiple pain indications, including osteoarthritis pain, chronic low back pain, and cancer pain.
Lilly currently carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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