Alector, GSK Get FDA Breakthrough Designation for Latozinemab
By Colin Kellaher
Alector and GSK have won U.S. Food and Drug Administration breakthrough-therapy designation for their latozinemab drug candidate for certain patients with one of the most common causes of early onset dementia.
The companies on Wednesday said the designation covers the potential treatment of frontotemporal dementia with a progranulin gene mutation.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.
Alector and GSK said frontotemporal dementia affects 50,000 to 60,000 people in the U.S. and 110,000 people in the European Union, and that patients with a progranulin gene mutation represent 5% to 10% of all people with the rare neurodegenerative disease.
Alector, a South San Francisco, Calif., clinical-stage biotechnology company, had signed an agreement with U.K. drug major GSK in July 2021 to develop and commercialize progranulin-elevating monoclonal antibodies, including latozinemab.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 07, 2024 07:49 ET (12:49 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
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