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.-
Magnificent 7 Stocks Earnings Updates: AI Remains the Focus
-
Small-Cap and Value Stocks Are Undervalued
-
Why We Expect the Job Market’s Slowdown to Renew in 2024
-
5 Undervalued Stocks to Buy to Play a Little Defense
-
Markets Brief: AI Leaders Excel In Earnings Season So Far
-
What History Tells Us About the Fed’s Next Move
-
What’s Happening In the Markets This Week
-
Alphabet’s New Dividend: What Investors Need to Know
-
Amazon Earnings: AWS Growth Accelerates and Profit Margins Improve
-
SiriusXM Earnings: Decent Results With Plan for Technology and Content Investment to Drive Growth
-
Coca-Cola Earnings: Solid Volume On Innovation and Digital Engagement
-
Is Berkshire Hathaway a Buy Before the Annual Meeting?
-
Investment Opportunities in the Drug Distribution Industry
-
Why the End of Quantitative Tightening Matters
-
Eli Lilly Earnings: Strong Weight-Loss Drug Sales Expand Margins
-
After Earnings, Is Meta Stock a Buy, a Sell, or Fairly Valued?