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Lilly's Emgality Gets FDA Approval for Cluster Headache

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Eli Lilly and Company (LLY - Free Report) announced that the FDA has granted approval to its CGRP antibody, Emgality injection (300 mg) for the preventive treatment of episodic cluster headache in adult patients.

Notably, Lilly gained an FDA approval for Emgality for preventive treatment of migraine late last September. The supplemental biologics license application for the cluster headache indication was based on data from a phase III study, which showed that 71.4% of patients who were given Emgality (300 mg) had their weekly cluster headache attacks reduced by half versus 52.6% of patients with placebo. Last September, the FDA granted Breakthrough Therapy status to Emgality for the same indication. The drug will be priced the same as for migraine on a per milligram basis

Lilly’s shares have risen 1.1% this year so far against the industry’s decline of 0.1%.



Amgen’s (AMGN - Free Report) and Novartis’ Aimovig and Teva’s (TEVA - Free Report) Ajovy were two other CGRP antibodies to be launched last year and pose strong competition to Emgality. However, Emgality now becomes the only CGRP antibody approved for two headache disorders - migraine and episodic cluster headache - which will help Lilly gain access to a broader patient population and boost sales of this promising drug. Currently, there are no approved medicines in the United States for treating episodic cluster headache.

In April, Lilly said that Emgality captured 33% share of market for new prescriptions in the United Statesin the first quarter of 2019, an increase of almost 13 points from end of 2018

Please note that Teva discontinueda late-stage study evaluating Ajovy for episodiccluster headache in April 2019 and one for chronic cluster headache in June last year.

According to Lilly’s press release, episodic cluster headache represents 85%-90% of cluster headache cases. Chronic cluster headache accounts for 10%-15% of the cluster headache market.

Notably, Lilly’s overall pain portfolio looks promising. Apart from Emgality, the company is developing lasmiditan, which is currently under review in the United States for the treatment of acute migraine in adult patients. Lilly along with partner Pfizer (PFE - Free Report) is developing tanezumab, which is being evaluated in several phase III programs for treating osteoarthritis pain, chronic low back pain and cancer pain in adult patients.

In a separate press release, Lilly announced that the FDA has accepted its new drug application looking for approval of a triple combination tablet for type II diabetes. The tablet is a fixed-dose single-pill combining of Lilly’s diabetes medicines, Jardiance (a SGLT-2 inhibitor) and Tradjenta (a DPP-4 inhibitor) plus with metformin extended release.

Lilly currently has 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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