Four major pharmaceutical companies are in a race to be the first to offer a drug they say may rapidly reduce—and even prevent—migraines to the more than 38 million Americans affected by the debilitating illness each year.
Alder Biopharmaceuticals, Eli Lilly, Amgen, and Teva Pharmaceutical have all developed migraine drugs which have completed or are currently undergoing Phase 3 clinical trials using a compound called calcitonin gene-related peptide (or CGRP) that contains antibodies that attack the protein in the brain that causes the severe headaches.
All four anti-CGRP trials currently underway by the separate companies are positive, showing very promising efficacy for patients and good safety profiles so far.
In terms of timing, Amgen’s drug is currently on track to be the first available to patients. Amgen says while the other companies are seeking federal approval, their CGRP drug called erenumab is the only one so far to file for a Biologics License Application with the FDA. Erenumab is specifically designed to prevent migraine by blocking the CGRP receptor in three pivotal studies. The drug has been shown to substantially reduce monthly migraine days in people at both low and high frequencies.
Eli Lilly plans to submit their new migraine drug, galcanezumab, with the FDA later this year after the drug also showed a reduction in migraine days during trials. Additionally, the company says they have developed a drug called lasmiditan to treat acute migraines that could represent “the first significant innovation” in treatments in more than 20 years.
Teva Pharmaceutical plans to submit an application to the FDA later this year with anticipated approval and launch of their drug fremanezumab during the second half of 2018 after reposting positive Phase 3 results.
Alder Biopharmaceuticals says their migraine drug, eptinezumab, is only currently undergoing Phase 3 testing and they don’t plan to submit with the FDA until the second half of 2018. During the company’s Phase 2b clinical trials, their drug—which is the only one infused by IV—showed a drastic reduction in migraines after a single administration.