| |AUGUST 20249RENALYS PHARMA COMMENCES PATIENT DOSING IN REGISTRATIONAL PHASE TRIAUK MHRA APPROVES VIBEGRON FOR OVERACTIVE BLADDER TREATMENT IN ADULTSRenalys Pharma, Inc. reported the dosing of the initial participant in its phase III clinical trial of sparsentan for IgA nephropathy treatment in Japan. Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in April of this year.The phase III clinical study for registration is a single arm, open-label, multicenter study for Japanese individ-uals with IgA nephropathy. It aims to validate the safety and effectiveness of sparsentan in around 30 Japanese pa-tients. Anticipated findings from the UP/C endpoint in the research will be available in the latter part of 2025 to back up a request for approval from PMDA.Travere Therapeutics, Inc created Sparsentan. Re-nalys Pharma holds a unique license to develop and sell Sparsentan in various Asian countries. In 2023, the FDA granted accelerated approval to Travere for sparsentan (known as Filspari in the US) to decrease proteinuria in adults with primary IgAN who are at risk of quick disease advancement.Furthermore, Travere filed an additional New Drug Application with the FDA in March 2024, which was des-ignated as Priority Review. The PDUFA target action date is set for September 5, 2024, to transition the current US accelerated approval to full approval using 2-year confir-matory data from the phase III PROTECT study, the sole head-to-head comparison in IgA nephropathy against an active comparator. In the PROTECT research, Filspari showed a notable decrease in proteinuria, maintenance of kidney function, and a well-received safety profile when compared to the active control irbesartan. POThe UK Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light for the medication vibegron (Obgemsa) to address symptoms of overactive bladder (OAB) syndrome in adult patients. Indications might consist of a sudden urge to urinate (urgency), increased frequency of urination (urinary frequency), and loss of bladder control (urinary incontinence).Pierre Fabre was granted a new marketing authorization for vibegron (Obgemsa) on 17th July, 2024.Vibegron, the active component in the medication, acts as a bladder muscle relaxant (a beta-3 adrenergic receptor agonist) that decreases the activity of an overactive bladder and addresses the associated symptoms. The suggested amount to take daily is one tablet. This medication is recommended in the form of a 75 mg tablet with a film coating.This endorsement is backed by data from a phase 3 clinical study. The EMPOWUR trial assessed vibegron in 1,515 OAB patients over 12 weeks, displaying urgency and urinary frequency symptoms, with or without urge urinary incontinence. Patients were given one daily dose of either placebo (n=540), vibegron 75 mg (n=545), or active control (n=430).The findings indicated that vibegron was successful in relieving OAB syndrome symptoms when compared to the placebo. Patients with overactive bladder syndrome experienced decreased daily urination and instances of incontinence. This was noticed after two weeks of the experiment and remained consistent for the entire 12-week duration of the therapy. The study results indicated that the benefits of the medication continue even after 52 weeks of therapy. PO | |AUGUST 20249
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