In a series of final-stage trials, an experimental drug has been found to significantly reduce the number of migraines suffered by study participants, bringing the medication closer to approval.
In three studies conducted by Indianapolis-based Eli Lilly & Co., patients taking the drug galcanezumab had approximately two fewer days with episodic and chronic migraines over the course of a month compared with those receiving a placebo, Lilly said Thursday in a statement. The company intends to file for approval of the drug with the U.S. Food and Drug Administration by the end of 2017.
Lilly is contending with drug companies Teva Pharmaceutical Industries Ltd., Amgen Inc. and Alder Biopharmaceuticals Inc. to develop migraine treatments using an anti-CGRP approach. Such drugs block the CGRP protein, which is thought to contribute to pain and migraines.
If the new drugs are approved by the FDA and can outsell older, generic migraine medications and Botox—which is used to treat migraines—they are expected to produce a multi-billion-dollar market. Analysts project that Lilly’s drug will produce approximately $480 million in sales in 2021, according to Bloomberg‘s data.
Lilly’s clinical studies, Evolve-1 and Evolve-2, followed patients who suffered from episodic migraines, while those in the Regain study were challenged with chronic migraines. Patients in Evolve studies had to experience between four and 14 days with migraines a month to be eligible to participate in the trial, while patients in the Regain study must have suffered with an average of 19.4 migraine days a month.
According to Lilly, the most common side effect in the three studies was pain and other reactions at the drug’s injection site.
Lilly also is testing galcanezumab for treating cluster headache, with final-stage trial results expected in 2018.
The Migraine Research Foundation reports that migraines are one of the most common neurological disorders with approximately 38 million people in the U.S., most of them women, suffering associated symptoms that extend beyond head pain, including vomiting and disturbed vision.
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