On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
University of Sydney spinout Kinoxis Therapeutics Pty announced a partnership and licensing agreement with Boehringer Ingelheim GmbH to develop first-in-class oxytocin-targeting precision psychiatry treatments to improve the quality of life of people living with neuropsychiatric disorders. Under the terms of the agreement, Kinoxis will receive an up-front payment and research support payments and is eligible for research, preclinical, clinical, regulatory and commercial milestones of up to AU$266 million (US$181 million), in addition to sales-based royalties.
In January, a Wall Street analyst predicted the U.S. FDA’s rejection of Eli Lilly and Co.’s application seeking accelerated approval of amyloid beta-targeting Alzheimer’s candidate, donanemab, would be a “mere footnote” in the drug’s development, a forecast confirmed in the wake of positive top-line phase III data showing donanemab significantly slowed cognitive and functional decline in people with early symptomatic disease.
Now that Avadel Pharmaceuticals plc has final U.S. FDA approval for its narcolepsy drug Lumryz, the company has priced the sodium oxybate formulation to match the cost of competitor Xywav from Jazz Pharmaceuticals plc. Avadel said it plans to charge $64.67 per gram for Lumryz. The annual cost based a 9-gram dose would be about $212,441 per patient. Three daily dose levels, 6 grams, 7.5 grams and 9 grams, were evaluated during a phase III study the final approval was based on.
U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure made her first appearance April 26 before the House Energy and Commerce’s Subcommittee on Health, ostensibly to discuss legislative solutions to increase transparency and competition in health care. But member after member, regardless of political party, demanded answers about why CMS continues to severely restrict access to Eisai Co. Ltd.’s Alzheimer’s drug, Leqembi (lecanemab), especially since another government agency is covering it for all veterans that meet the labeling requirements.
Xian Janssen Pharmaceutical Ltd. obtained marketing approval in China for Spravato (esketamine hydrochloride nasal spray) in combination with an oral antidepressant to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Unlike existing antidepressants on the market, which can take weeks to take effect, the newly approved nasal spray shows effects right away.
The U.S. FDA’s green light April 17 for Abbvie Inc. to expand the label of Qulipta (atogepant) – the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine, with language that includes prevention of such headaches chronically in adults – provided a welcome addition to the arsenal, but sufferers are still waiting for an improved remedy. Vaxxinity Inc. just might have it. And with a vaccine, no less.
Shin Nippon Biomedical Laboratories Ltd. (SNBL) agreed to acquire Satsuma Pharmaceuticals Inc.as part of a deal worth as much as $220 million that includes rights to the STS-101 migraine drug. Shin Nippon will pay 91 cents in cash per share, as well as a non-tradeable contingent value right worth up to $5.77 per share based on the potential sale, license, or other grant of rights of Satsuma’s migraine drug STS-101.
After issuing three prior complete response letters, the U.S. FDA finally granted approval via the 505(b)(2) NDA pathway to Intelgenx Corp.’s Rizafilm Versafilm to treat acute migraine.
As expected, the serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease (AD) dementia, found favor April 14 at the joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee.
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