February 27, 2020 / 11:22 PM / a month ago

Biohaven drug wins U.S. FDA approval for use in relieving migraine headaches

(Reuters) - The U.S. Food and Drug Administration on Thursday approved Biohaven Pharmaceutical Holding Co Ltd’s oral pill for relieving pain after the onset of migraine headaches, the drug developer said.

FILE PHOTO: The logo for Biohaven Pharmaceutical Holding Company is displayed on a screen during the company's IPO on the floor of the New York Stock Exchange (NYSE) in New York, U.S., May 4, 2017. REUTERS/Brendan McDermid

The company’s shares were up 5.3% at $40.82 in extended trading.

Nurtec ODT, chemically known as rimegepant, belongs to an emerging class of migraine treatments called calcitonin gene-related peptide (CGRP) inhibitors and directly competes with Allergan Plc’s Ubrelvy, which became the first oral CGRP to be approved for acute migraine in December.

A single oral dose of the 75 mg tablet can provide fast pain relief, return patients to normal function within an hour, and remain effective for up to 48 hours for many patients, the company said.

Biohaven is vying for a slice of the crowded migraine market with rimegepant, which is also being studied for its application in migraine prevention.

The company said 86% of patients treated with a single dose of the pill did not use a migraine rescue medication within 24 hours.

Biohaven bets on rimegepant’s oral use and its dual application to help it stand out from rival drugs. Most other CGRP inhibitors approved for migraine prevention are administered by injections.

“We think there’s a value-add for payers and patients by not having to pay for two different drugs - one for acute and one for prevention”, Biohaven Chief Executive Officer Vlad Coric told Reuters.

Rimegepant’s largest opportunity will be in the treatment of acute migraine, given the increasing size of that market and a less-competitive environment than what now exists in migraine prevention, Mizuho analyst Vamil Divan said in a note prior to the approval.

Other rival products such as Amgen Inc and Novartis AG’s Aimovig, Eli Lilly and Co’s Emgality and Teva Pharmaceutical Industries Ltd’s Ajovy are jostling for space in the prevention market after winning approval within months of each other in 2018.

Divan expected Rimegepant to bring in about $1 billion in sales by 2030, for its use in acute migraine treatment.

Reporting by Manojna Maddipatla and Sanjana Shivdas in Bengaluru; Editing by Shailesh Kuber

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