Biohaven’s Migraine Pill Is the Latest CGRP Drug to Win the FDA’s OK

Xconomy New York — 

[Updated 2/28/2020, 2:45 p.m. See below.] A Biohaven Pharmaceutical migraine drug has won FDA approval, clearing the way to the market for a new treatment option for the millions of people who suffer from the debilitating condition.

The Biohaven (NYSE: BHVN) drug rimegepant (Nurtec) was developed for acute migraine in adults, treating a migraine attack as it occurs. The drug, a tablet, is designed to dissolve quickly and provide fast pain relief. It’s the first drug from the New Haven, CT-based company to earn a regulatory nod.

Migraine affects an estimated 39 million men, women, and children in the US, according to the Migraine Research Foundation. Until relatively recently, patients could only choose among decades-old treatments for relief, some of them not even developed as migraine treatments. In the past five months, four new migraine drugs, including Biohaven’s, have been approved by the FDA.

Biohaven’s rimegepant is part of a new drug class that blocks calcitonin gene-related peptide, a protein whose levels increase during a migraine attack. The first CGRP drugs to reach the market two years ago were antibody drugs administered as injections. These drugs were approved for migraine prevention. Taken monthly, or in some cases every three months, the injections are meant to reduce the frequency of a patient’s migraine attacks. These CGRP injectables became the first drugs specifically approved for migraine prevention. Last Friday, the FDA approved a fourth CGRP migraine-prevention drug, Lundbeck’s intravenous infusion eptinezumab (Vyepti).

CGRP has also been studied as a way to treat acute migraine. Late last year, Allergan (NYSE: AGN) won FDA approval for its CGRP pill, ubrogepant (Ubrelvy). Thursday’s decision for the Biohaven drug provides a CGRP competitor to the Allergan pill. Those drugs follow a new acute migraine treatment from Eli Lilly (NYSE: LLY), lasmiditan (Reyvow), which was approved last October. The Lilly drug doesn’t block CGRP, but instead binds to a receptor called 5-HT1F.

[Paragraph added with executive comments; remainder of story updated with additional details.] Speaking on a conference call Friday, Biohaven CEO Vlad Coric said several features of his company’s drug can help it stand out in the growing field of new migraine medications. For example, rimegepant instantaneously dissolves in a patient’s mouth without the need for water. That means the drug starts to work quickly. He added that the pain relief from a single dose lasts for up to two days. “This is a real differentiator for our product,” Coric said.

Biohaven licensed rimegepant from Bristol-Myers Squibb (NYSE: BMY) in 2016. The biotech’s clinical program evaluated the drug in more than 3,100 patients. The FDA decision for the drug is based on results of a Phase 3 study that achieved the main goal of showing relief from pain and other symptoms within two hours. The most common adverse reaction, observed in 2 percent of patients in the study, was nausea. The safety of treating more than 15 migraines per month with rimegepant has not been established.

Rimegepant’s approval comes days after the Institute for Clinical and Economic Review (ICER) released its final report regarding acute migraine treatments. The drug price watchdog group said it found no evidence that the new acute migraine drugs—rimegepant, ubogepant, and lasmiditan—are better than triptans, an older class of acute migraine drugs that are currently the standard of care. But ICER noted that some patients are either unable to take triptans, or they don’t get sufficient pain relief from these older drugs. Those patients might benefit from the new acute migraine medications, ICER said.

For the benefit that patients receive for acute migraine relief, ICER said these drugs would be cost effective priced in the range of $4,200 to $4,600 per year. That’s below the $4,896 annual list price for Allergan’s ubrogepant. Biohaven is not releasing the wholesale price for its migraine drug until it becomes available to pharmacies, but William “BJ” Jones, the company’s chief commercial officer, said that the price will be within ICER’s range.

Biohaven plans to make rimegepant available to pharmacies by mid-March. The company will supply the drug in packs of eight. Patients will be instructed to take one pill per migraine attack, but not more than one pill per day.

Biohaven is also developing another CGRP drug, vazegepant, for both acute migraine treatment and migraine prevention. The company says vazegepant is structurally different than rimegepant, boasting chemical properties that make it suitable for intranasal delivery, subcutaneous injection, inhalation, or oral dosing. “We believe that intranasal vazegepant may provide an ultra-rapid onset of action that could be used in a complementary fashion with other migraine treatments when the speed of onset is critical to a patient,” Biohaven says in its annual report.

Late last year, Biohaven reported positive Phase 2/3 data for vazegepant at two different doses. A Phase 3 study aimed at replicating those results is planned for mid-2020.

Photo by Biohaven Pharmaceutical