19:07 uur 23-02-2021

Altasciences voert Fase I studies uit voor goedkeuring Vibegron door FDA

LAVAL, Quebec– (BUSINESS WIRE) – Altasciences is verheugd te hebben bijgedragen aan de recente FDA-goedkeuring van Vibegron door drie vroege fase klinische onderzoeken uit te voeren. Vibegron is een bèta-3-adrenerge receptor (β3) -agonist voor de behandeling van een overactive bladder (OAB) met symptomen van urge urinary incontinence (UUI), urgentie en frequentie van plassen bij volwassenen. De goedkeuring werd op 23 december 2020 aangekondigd door Urovant Sciences.

“We zijn enorm trots om bij te dragen aan de goedkeuring door de FDA van de hoognodige geneesmiddelen die de gezondheid en het welzijn van patiënten verbeteren”, zegt Amy Denvir, General Manager bij Altasciences ’Kansas Clinical Pharmacology Unit. “Het was een genoegen om met Urovant Sciences aan dit programma te werken, en we zijn verheugdom het tot bloei te zien komen.”

Altasciences Performs Phase I Studies for FDA Approval of Vibegron

LAVAL, Quebec–(BUSINESS WIRE)– Altasciences is pleased to have contributed to the recent FDA approval of Vibegron, by performing three early phase clinical trials. Vibegron is a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. The approval was announced by Urovant Sciences on December 23, 2020.

We take tremendous pride in contributing to the FDA approval of much-needed medicines that improve the health and wellbeing of patients,” said Amy Denvir, General Manager at Altasciences’ Kansas clinical pharmacology unit. “Working with Urovant Sciences on this program has been a pleasure, and we are delighted to see it come to fruition.

Altasciences’ expert clinical teams provided clinical support for two drug-drug interaction studies and a bioavailability trial, conducted in 2018 and 2019, in healthy subjects. These trials were supported by Altasciences’ data services team, who performed the full data management and reporting for the associated clinical studies.

About Altasciences

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

Contacts

Julie-Ann Cabana
Altasciences
+1 514 601-9763

jcabana@altasciences.com

Check out our twitter: @NewsNovumpr