CASTRES, France, April 26, 2024 /PRNewswire/ -- Pierre Fabre
Laboratories announced that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a positive opinion recommending approval of OBGEMSA™
(vibegron under the international non-proprietary name) for the
symptomatic treatment of adult patients with overactive bladder
syndrome (OAB). Pierre Fabre Laboratories acquired an exclusive
license from Urovant Sciences to register and commercialize
vibegron in the European Economic Area in 2022. OBGEMSA™ is a
trademark owned by Urovant Sciences GmbH.
The CHMP recommendation will now be reviewed by the European
Commission (EC), which may decide on the marketing authorisation
(MA) for OBGEMSA™ (vibegron). The decision will then be applicable
to all member states of the European Union as well as to
Iceland, Liechtenstein and Norway.
" We are very pleased to have received this positive opinion
from the CHMP for OBGEMSA™. If approved, this
innovative therapeutic solution has the potential to help patients
suffering from overactive bladder, a condition that is very
debilitating in daily life. We have been working in the field of
urology for more than 40 years and OBGEMSA is proof of our
determination to continue our development in this area."
said Eric DUCOURNAU, CEO of Pierre Fabre Laboratories.
The CHMP positive opinion is based on positive data from
two Phase 3 pivotal, randomized, multicenter and double-blind
studies in patients with symptoms of overactive bladder. Study
RVT-901-3003 assessed the efficacy, tolerability and safety at 12
weeks of vibegron (at a dose of 75 mg/daily) compared to placebo
and tolterodine (as positive control). Its extension, Study
RVT-901-3004, assessed the long-term safety, tolerability and
efficacy of vibegron at 52 weeks versus tolterodine. In these
studies, vibegron, as a new beta-3 adrenergic receptor (ß3 AR)
agonist, demonstrated a favourable risk-benefit profile in the
symptomatic treatment of urgency, increased micturition and urge
urinary incontinence (UUI) that may occur in patients with OAB
syndrome.
The CHMP positive opinion is also supported by clinical data
from the study URO-901-1001, a randomized, Phase 1,
double-blind, placebo-controlled, parallel-group study in subjects
with OAB, designed to study the effect of vibegron (at a dose of 75
mg daily or placebo once daily) for a duration of 28 days at
steady state on ambulatory blood pressure (BP) and heart rate (HR).
Results from this study confirm that vibegron 75 mg had no
statistically significant or clinically meaningful effects on Blood
Pressure or Heart Rate in patients with symptoms of OAB.
About overactive bladder (OAB)
The OAB syndrome is
clinically characterized by urinary urgency (i.e. a sudden
compelling desire to void that is difficult to defer), with or
without urge urinary incontinence UUI, and usually accompanied by
urinary frequency and nocturia in the absence of urinary tract
infection or other obvious pathology. UUI is the involuntary loss
of urine accompanied by urgency. UUI is distinguished from stress
urinary incontinence, which is the involuntary loss of urine on
effort or physical exertion (e.g., sporting activities), or on
sneezing or coughing. When both components are present, the
classification is mixed urinary incontinence, with either urgency
or stress specified as the predominant component. From a
pathophysiological perspective, the OAB symptom complex is
suggestive of detrusor overactivity, which may be intrinsic or may
be secondary to neurological conditions such as stroke or spinal
cord injury.
About vibegron
Vibegron is a novel, potent, and
selective human beta-3 adrenergic receptor (β3-AR) agonist. Beta
receptors are found throughout the body, but β3-ARs are
predominantly found on human detrusor smooth muscle. β3-ARs
agonists bind to and activate beta-3 receptors on the detrusor
muscle, leading to relaxation of the detrusor muscle to increase
vesical capacity and to reduce OAB symptoms. Vibegron received
approval in the U.S. in December 2020
(at 75 mg once daily, under the tradename GEMTESA®) for the
treatment of OAB with symptoms of UUI, urgency, and urinary
frequency in adults and in Japan
and in the Republic of Korea, respectively in September 2018 and in October 2022 (at 50 mg once daily, under the
tradename BEOVA®) for the treatment of OAB in adults. GEMTESA is a
trademark of Urovant Sciences GmbH, and registered in the U.S., and
in other countries. In the U.S., GEMTESA is marketed by Sumitomo
Pharma America, Inc.
About Pierre Fabre Laboratories
For more information,
visit www.pierre-fabre.com, @PierreFabreGroup.
PRESS CONTACT :
PIERRE FABRE
Anne Kerveillant, anne.kerveillant@pierre-fabre.com
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