Exclusive: US FDA finds new manufacturing lapses at Eli Lilly plant
June 16 (Reuters) - Eli Lilly (LLY.N) said on Friday its migraine prevention drug failed to show superiority to a rival from Pfizer Inc (PFE.N) in a post-approval study.
INDIANAPOLIS, June 16, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results of the CHALLENGE-MIG clinical trial of Emgality® (galcanezumab-gnlm) and Nurtec® ODT (rimegepant orally disintegrating tablet), the first and only trial of its kind comparing two calcitonin gene-related peptide (CGRP) antagonist therapies. Emgality did not meet the study's primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days. Response rates were similar. However, it demonstrated clinically meaningful efficacy and safety in this 3-month study consistent with Emgality's previous 6-month studies. And, Emgality performed numerically better on key secondary endpoints of the 3-month trial.
Eli Lilly had some of the most disappointing sales figures in Q2 for its migraine prevention drug Emgality, FDA-approved four years ago, which saw sales hit $157.5 million, an increase of just 1% compared to the year-ago period.
Eli Lilly and Company has commenced subject enrolment in Phase IV nCHALLENGE-MIG clinical trial Emgality (galcanezumab-gnlm) injection as anpreventive therapy for episodic migraine in adult patients.
Eli Lilly Japan and Daiichi Sankyo Company have concluded an agreement on commercialization collaboration in Japan for the 5-HT1F receptor agonist lasmiditan succinate, for which Eli Lilly Japan has submitted a new drug application for the treatment of migraines.
One of the gems AbbVie inherited from the $63 billion Allergan transaction is ready to take a slice of the highly competitive migraine market—and no, it’s not Botox.
TORONTO, Feb. 25, 2021 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce that Emgality® (galcanezumab) is now indicated for the reduction in the frequency of attacks throughout a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines. i