U.S. FDA declines to approve Spero's urinary tract infection drug – Reuters

U.S. FDA declines to approve Spero's urinary tract infection drug – Reuters

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
June 27 (Reuters) – The U.S. Food and Drug Administration (FDA) declined to approve Spero Therapeutics Inc’s (SPRO.O) oral antibiotic drug for the treatment of patients with complicated urinary tract infections, the company said on Monday.
In the complete response letter, the health regulator concluded that Spero’s late-stage study testing the drug was insufficient and an additional study would be required, the drugmaker said.
Shares of Spero fell about 14% after the bell.
Spero had sought approval for its most advanced drug candidate, tebipenem, to treat the infections, including a type of kidney inflammation called pyelonephritis in adult patients with limited oral treatment options.
But the company suffered a setback in March when the agency found certain deficiencies in the drug’s marketing application. Spero later suspended commercialization activities for tebipenem and slashed its workforce by about 75%, as the FDA’s feedback suggested that the data on the drug could be insufficient to obtain approval.
The drugmaker said on Monday it intends to promptly request a meeting with the health regulator.
Our Standards: The Thomson Reuters Trust Principles.
Abortions can resume in Texas after a judge on Tuesday blocked officials from enforcing a nearly century-old ban the state’s Republican attorney general said was back in effect after the U.S. Supreme Court overturned the constitutional right to the procedure nationwide.
Reuters, the news and media division of Thomson Reuters, is the world’s largest multimedia news provider, reaching billions of people worldwide every day. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world’s media organizations, industry events and directly to consumers.
Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology.
The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs.
The industry leader for online information for tax, accounting and finance professionals.
Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile.
Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts.
Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks.
All quotes delayed a minimum of 15 minutes. See here for a complete list of exchanges and delays.
© 2022 Reuters. All rights reserved

source


Leave a Reply

Your email address will not be published.