Eli Lilly and Company (LLY - Free Report) announced that the FDA has approved its calcitonin gene-related peptide (CGRP) antibody, Emgality (galcanezumab), for the preventive treatment of migraine in adults. The drug is approved as a once-monthly, self-administered, subcutaneous 120 mg injection. The company confirmed about the injection’s imminent launch.
The drug’s label mentions that patients suffering serious hypersensitivity should not be using the drug.
This is the third CGRP antibody to get an FDA nod for migraine treatment this year. While Teva’s (TEVA - Free Report) fremanezumab was approved earlier in September under the trade name of Ajovy, Amgen’s (AMGN - Free Report) and Novartis’ (NVS - Free Report) CGRP antibody, Aimovig/erenumab, was approved and launched in the United States during the second quarter of 2018. Considering that migraine has limited treatment options, the anti-CGRP comes as a new treatment mechanism.
Eli Lilly has set the price for Emgality as $575 for once-monthly or $6,900 annually in the United States. The annual price of Ajovy and Aimovig are on par with Emgality.
Shares of Eli Lilly have rallied 26.4% year to date, comparing favorably with the industry’s increase of 6.8%.
The FDA approval was based on data from two phase III clinical studies — The EVOLVE-1 and EVOLVE-2 as well as REGAIN. The first couple of analyses, spanning six months each, evaluated Emgality for the prevention of episodic migraine. While the third phase III REGAIN study with duration of three months was conducted on patients with chronic migraine. Data from all three programs showed that treatment with Emgality (120 mg) significantly lowered the mean monthly migraine headache days as compared to placebo.
Notably, Lilly's patient support program will help patients with commercial insurance (excluding governmental beneficiaries) to receive Emgality for free of cost up to 12 months.
Earlier this week, the Committee for Medicinal Products for Human Use (CHMP) conveyed a positive response, recommending approval for Emgality in Europe with a decision expected anytime soon.
Eli Lilly and Company Price and Consensus
Eli 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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