OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options. The Advisory Committee voted 14 to 2 that Shionogi provided substantial evidence about the efficacy and sufficient evidence of the safety of cefiderocol as part of its New Drug Application (NDA).
“We are pleased with the positive recommendation for the approval of cefiderocol for the treatment of cUTI. We appreciate the conscientious review of our data by the committee members and will continue to work closely with the FDA as it completes the review of our submission,” said Isao Teshirogi, Ph.D., president and CEO. “Patients with cUTIs caused by Gram-negative pathogens continue to face a serious challenge with high morbidity and mortality rates. If approved, we believe cefiderocol could help address a significant unmet need in an area with limited treatment options to fight these life-threatening infections.”
The Advisory Committee provides the FDA with independent advice and recommendations. The FDA is not bound by the committee’s guidance, but takes its recommendation into consideration when reviewing investigational medicines. Cefiderocol was designated as a Qualified Infectious Disease Product (QIDP) by the FDA. Under this designation, cefiderocol was granted Fast Track status for its potential as a new antibiotic to treat serious or life-threatening conditions and to address unmet medical needs. The assigned action date is November 14, 2019 under the Prescription Drug User-Fee Act (PDUFA).
If approved, cefiderocol will be marketed under the brand name FETROJA®.
For additional information about the October 16, 2019 Advisory Committee meeting, please visit https://www.fda.gov/advisory-committees/advisory-committee-calendar/october-16-2019-antimicrobial-drugs-advisory-committee-meeting-announcement-10162019-10162019.
About Cefiderocol–An Investigational Antibiotic Agent
About Gram-negative Infections
Shionogi & Co., Ltd. is a Japanese major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, cardiovascular diseases, and gastroenterology. Our pipeline is focused on infectious disease, pain, CNS, and oncology. For more information on Shionogi & Co., Ltd., visit www.shionogi.co.jp/en. Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit https://www.shionogi.com/.
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials, and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.
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