Eli Lilly and Company (LLY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for Emgality (galcanezumab) in Europe. The marketing authorization application (MAA) is seeking an approval for the calcitonin gene-related peptide (CGRP) antibody for treating migraine in adults, who encounter at least four migraine attacks per month.
The positive CHMP response will now be reviewed by the European Commission with a decision expected soon.
Shares of Eli Lilly have rallied 25.9% year to date, comparing favorably with the industry’s increase of 7.2%.
The positive opinion was based on data from two phase III clinical studies, namely EVOLVE-1 and EVOLVE-2, which evaluated Emgality for the prevention of episodic migraine and another phase III REGAIN study conducted on patients with chronic migraine. Data from all three evaluations showed that in the first month of treatment, Emgality significantly lowered the mean monthly migraine days and followed it every month during the therapy as compared to placebo.
Emgality is currently under review in the United States with a decision expected by the end of this month.
Earlier this month, the FDA granted a nod to Teva Pharmaceuticals’ (TEVA - Free Report) anti CGRP drug, Ajovy (fremanezumab) injection, as a preventive treatment of migraine.
We would like to remind investors that migraine has limited treatment options and anti-CGRP is a new treatment mechanism. Amgen (AMGN - Free Report) and Novartis’ (NVS - Free Report) anti CGRP drug Aimovig (erenumab) was also approved and launched for prevention of migraine in second-quarter 2018.
Eli 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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