GEPOTIDACIN ACCEPTED FOR PRIORITY REVIEW BY US FDA FOR TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS IN FEMALE ADULTS AND ADOLESCENTS
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GEPOTIDACIN ACCEPTED FOR PRIORITY REVIEW BY US FDA FOR TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS IN FEMALE ADULTS AND ADOLESCENTS
GSK has announced that the US Food and Drug Administration ( FDA ) has accepted the New Drug Application ( NDA ) for gepotidacin , an investigational , firstin-class oral antibiotic with a novel mechanism of action for the treatment of female adults and adolescents with uncomplicated urinary tract infections ( uUTIs ).
The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act ( PDUFA ) action date of 26 March 2025 .
The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials of gepotidacin . The most commonly reported adverse events ( AEs ) in gepotidacin participants were gastrointestinal ( GI ). Diarrhoea was the most common ( 16 % of participants ), followed by nausea ( 9 %). Of the participants who reported GI AEs in the gepotidacin group , the maximum severity were mild ( 69 % Grade 1 ) and moderate ( 28 % Grade 2 ). Participants with Grade 3 GI events accounted for 3 % of all patients with GI events and occurred in < 1 % of all participants . There was one drug-related serious adverse event in each treatment arm ( gepotidacin and nitrofurantoin ) across the two trials .
Over half of all women are affected by uUTIs in their lifetime , with approximately 30 % suffering from recurrent disease which can cause significant patient burden , including discomfort and restriction of daily activities . New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates . Gepotidacin is a late-stage antibiotic in GSK ’ s growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years .
JOHNSON & JOHNSON TO INVEST MORE THAN US $ 2 BILLION IN NEW , ADVANCED TECHNOLOGY MANUFACTURING FACILITY IN NORTH CAROLINA TO SUPPORT ROBUST PORTFOLIO GROWTH
Johnson & Johnson has announced an investment of more than US $ 2 billion to build a state-of-the-art biologics manufacturing facility in Wilson , North Carolina . The new facility will expand production of the Company ’ s portfolio and pipeline of innovative biologics in support of Johnson & Johnson ’ s broader plan to advance more than 70 novel therapy and product expansion filings and launches by the end of the decade .
“ A strong , global supply chain is crucial , and we purposefully invest to ensure our transformational medicines reliably and efficiently reach patients around the world ,” said Dapo Ajayi , Vice President , Innovative Medicine Supply Chain , Johnson & Johnson . “ We are investing in capacity and new technologies to enhance our industry leading capabilities and ensure a resilient supply chain for the future . North Carolina is an important hub for biopharmaceutical manufacturing and talent , and we are pleased to join this thriving life sciences ecosystem and become part of the Wilson community .”
The new facility will expand production of Johnson & Johnson ’ s innovative biologic medicines in areas including oncology , immunology and neuroscience , with the latest technology focused on enabling efficient manufacturing operations . When fully operational , the site will employ approximately 420 full-time , highly skilled employees . Construction is anticipated to begin in the first half of 2025 .
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