Eli Lilly in September joined its rivals in the CGRP drug class with a third-to-market nod for Emgality to prevent migraines. Now, the company is ratcheting up efforts to secure an approval for another patient population.
The FDA Wednesday granted a Breakthrough Therapy Designation for Lilly’s Emgality for its ability to prevent cluster headaches, and the drugmaker now plans to file for approval in the use by the end of the year. The breakthrough tag is designed to speed up the regulatory process for drugs that represent an improvement over current treatments.
In May, Lilly reported that Emgality met its endpoint in a phase 3 cluster headache trial. The drug reduced cluster headache attacks compared to placebo in Week 1 to Week 3 in a two-month test, the company said.
Along with the Emgality news, Lilly said Wednesday that it it filed an application for candidate lasmiditan to treat migraines. If approved, the drug would be the first new migraine treatment in two decades.
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Lilly won its initial nod for Emgality to prevent migraines in September, following Amgen's Aimovig and Teva's Ajovy into the CGRP field. Even though it won a later approval than its rivals, Lilly VP of neuroscience Wei-Li Shao said at the time his company is aiming for the drug to be the “treatment of choice” in the CGRP class.
Since then, Amgen and Eli Lilly have scored an important coverage decision from Express Scripts, which opted to shut out the Teva option. All three drugs carry list prices of $6,900 per year.
Cluster headaches cause intense pain, last 15 minutes to three hours and occur in spurts, often daily or multiple times per day. They can stop for months or years, but can start up again with no warning. They’re associated with pain around one eye, restlessness and anxiety.