In the Biohaven Pharmaceutical Holding Co. Ltd. and Pfizer Inc. collaboration to commercialize Nurtec ODT (rimegepant) outside the U.S., Biohaven will receive tiered double-digit royalties on ex-U.S. net sales as well as milestone payments of up to $1.24 billion. The target: more than 1 billion migraine sufferers worldwide with lots of clinical competition.
With the FDA approval of Abbvie Inc.’s Qulipta (atogepant) to prevent episodic migraine in adults, the oral calcitonin gene-related peptide (CGRP) receptor antagonist became the first specifically developed for preventing migraine.
The FDA has approved Trudhesa (dihydroergotamine mesylate [DHE]; INP-104) from Impel Neuropharma Inc. for treating acute migraine headaches with or without aura in adults. The approval comes as several competitors, including Axsome Therapeutics Inc and Abbvie Inc., have NDAs submitted or approved for new therapies to treat migraine.
The U.S. Court of Appeals for the Federal Circuit didn’t change a thing in a trio of rulings stemming from Eli Lilly and Co.’s inter partes review challenges of several patents protecting Teva Pharmaceutical Industries Ltd.’s migraine drug, Ajovy (fremanezumab).
The second oral CGRP antagonist to win FDA approval for acute migraine care is now the first to add preventive treatment to its label, marking a valuable win for Biohaven Pharmaceutical Holding Co. Ltd. and its oral dissolving tablet, Nurtec (rimegepant). The U.S. approval, for preventive treatment of episodic migraine, officially blesses a use for the medicine already adopted by many doctors, Piper Sandler analyst Christopher Raymond wrote, while opening up a potentially rich new stream of revenue for Biohaven.
TORONTO – For Scott Kadwell, president of Markham, Ontario-based RSK Medical Inc., the distributor tagged to sell the Health Canada approved Gammacore Sapphire, the device represents “a shift from a business to business to a direct-to-consumer business model.” For Rockaway, N.J.’s Electrocore Inc. which developed the self-administered technology, it’s one more regulator to have greenlighted the FDA cleared, CE-marked device for treating intractable migraine and cluster headache.
Neurolief Ltd. received FDA clearance for its Relivion system for home treatment of acute migraine. The noninvasive multichannel brain neuromodulation system, worn as a headset, stimulates the occipital and trigeminal nerves.
Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.
Using in vivo imaging technology, investigators at the University of Utah and the University of Padua have identified a new signaling mechanism for glutamate that was linked to the onset of spreading depression or spreading depolarization, a neuronal activity pattern that plays a role in multiple neurological disease states. In mouse models of migraine, glutamate, which is the major excitatory neurotransmitter of the brain, was released in what the authors called "plumes" or puffs.
Using in vivo imaging technology, investigators at the University of Utah and the University of Padua have identified a new signaling mechanism for glutamate that was linked to the onset of spreading depression or spreading depolarization, a neuronal activity pattern that plays a role in multiple neurological disease states.
