Migraine drug from Eli Lilly approved by FDA

Eli Lilly and Co. received clearance Thursday from U.S. regulators for a new migraine drug that will be the third in a promising class of therapies for patients who suffer from the recurrent, painful headaches.

The Food and Drug Administration approved galcanezumab, a so called CGRP-inhibitor that will be marketed under the name Emgality.

Indianapolis-based Lilly said it will offer the drug at no cost for a year to millions of patients with commercial insurance, a move that reflects increased scrutiny of high prescription costs in the United States and fierce competition in a hot treatment area.

Under that strategy, Lilly will be able to ensure patients are getting its medication even as insurers finalize coverage or reimbursement policies.

“We’re providing this to make sure there’s no gap in the ability for patients to start should they need it,” said Wei-Li Shao, vice president of Lilly’s neuroscience business.

Emgality is forecast to hit $701 million in sales in 2022, according to data compiled by Bloomberg. Shao said most people who suffer migraines are between the ages of 35 and 45 and have insurance. CGRP drugs are expected to become a $2.2 billion market in the U.S., Bloomberg Intelligence estimates.

Migraines are very common, with about 39 million people in the U.S., most of them women, suffering symptoms that can also include vomiting and disturbed vision, according to the Migraine Research Foundation. CGRP inhibitors are the first drugs specifically approved for prevention of migraines.

“The unmet need in this marketplace is huge,” Shao said. “There are over 30 million people that are actually suffering from migraine, and surprisingly only about 10 percent are taking any prescription drugs right now for the prevention of migraine.”

Lilly said that Emgality will be priced at $6,900 a year, or $575 a month, in line with similar drugs recently launched by Amgen Inc. and Teva Pharmaceuticals Industries Ltd. Amgen allows commercial insurance patients a $5 monthly copayment for its drug Aimovig, although patients will be capped at a benefit of $2,700 a year, the company said. Teva’s Avovy is available for patients with commercial insurance for no copay through the end of 2019, when the company plans to reevaluate its assistance program.

Companies selling drugs in crowded spaces face different challenges than those launching ones for rare diseases or ailments without competition. Lilly, Amgen and Teva are jostling for position on the lists of treatments that insurers will cover. Lilly will be absorbing the cost of Emgality doses given away until insurance contracts are finalized.

Drug pricing remains a politically charged topic in the U.S. There is an effort, spearheaded by the Trump administration, to get rid of rebates that drugmakers use to compete for coveted sports on pharmacy benefit managers’ lists of covered drugs. The discounts can help lower overall costs.