–Supplemental New Drug Application
(sNDA) submission based on Phase 3 study of
vibegron 75mg (GEMTESA) demonstrating
statistically significant reductions in daily micturition and
urgency episodes–
–If approved, vibegron will be the first and
only beta-3 agonist for the treatment of men with OAB symptoms
receiving pharmacological therapy for BPH–
MARLBOROUGH, Mass., May 13, 2024
/PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA),
announced today the U.S. Food and Drug Administration (FDA) has
accepted its supplemental New Drug Application (sNDA) for vibegron
(GEMTESA®), a beta-3 adrenergic receptor (β3) agonist,
dosed once-daily (75 mg), for the treatment of men with overactive
bladder (OAB) symptoms receiving pharmacological therapy for benign
prostatic hyperplasia (BPH). If approved, vibegron will be the
first and only beta-3 agonist for the treatment of men with OAB
symptoms receiving pharmacological therapy for BPH. The FDA has set
a target action date in Q3 of FY2024, under the Prescription Drug
User Fee Act (PDUFA).
The sNDA is supported by the results from URO-901-3005 a Phase 3
multicenter, randomized, double-blind, parallel-group, fixed-dose
study, which evaluated the efficacy, safety, and tolerability of
vibegron versus placebo over 24 weeks in approximately 1,100 men
with OAB symptoms receiving pharmacological therapy for BPH. The
study met all co-primary endpoints at Week 12, demonstrating
statistically significant reductions from baseline in the average
number of micturition (urination) episodes per day and in the
average number of daily urgency episodes (the sudden urge to
urinate that is difficult to control) compared to placebo as well
as all secondary endpoints, including reduction of nocturia
episodes (awakening to use the bathroom per night) and instances of
urge urinary incontinence episodes (unintentional loss of urine
immediately after an urgent need to urinate) per day. Vibegron was
well-tolerated throughout the study and there were no new safety
signals compared to prior vibegron studies.
"This milestone is important in our efforts to bring novel
treatments to those living with urological conditions including OAB
and BPH," said Tsutomu Nakagawa,
Ph.D, President and Chief Executive Officer of SMPA. "We are
pleased the FDA has recognized the strength of the Phase 3 data for
vibegron in the URO-901-3005 study within our application. We look
forward to working with the FDA during the review period in the
hopes of potentially providing a new, safe, and effective treatment
option for men struggling with OAB symptoms receiving
pharmacological therapy for BPH."
BPH is increasingly prevalent in men as they get older and
associated symptoms of OAB can often be mistaken as a natural part
of aging. Nearly half of all men between ages 51 and 60 have BPH
while up to 90% of men over age 80 have BPH.1
Approximately 46% of patients with bladder outlet
obstruction secondary to BPH also have OAB.2
Vibegron is currently approved for OAB with symptoms of urge
urinary incontinence, urgency, and urinary frequency in adults.
About GEMTESA (vibegron)
Vibegron, a once-daily beta-3
adrenergic receptor (β3) agonist, is currently under investigation
for the treatment of men with overactive bladder (OAB) symptoms
receiving pharmacological therapy for benign prostatic hyperplasia
in the United States (U.S.). In the U.S., GEMTESA
(vibegron) has been indicated for the treatment of OAB with
symptoms of urge urinary incontinence, urgency, and urinary
frequency in adults since April 2021. GEMTESA works by
selectively targeting β3 adrenergic receptors to reduce OAB
symptoms through the relaxation of the bladder detrusor muscle to
increase capacity. In China and Europe, vibegron is currently under
investigation in a Phase 3 clinical study for the treatment of
OAB.
About Overactive Bladder
Overactive bladder (OAB) is a
clinical condition that occurs when the bladder muscle contracts
involuntarily. Symptoms may include urinary urgency (the sudden
urge to urinate that is difficult to control), urgency incontinence
(unintentional loss of urine immediately after an urgent need to
urinate), and frequent urination (usually eight or more times in 24
hours).3 About 33 million U.S. adults experience
the bothersome symptoms of OAB.4
About Benign Prostatic Hyperplasia
Benign
prostatic hyperplasia (BPH) is a condition in men in which the
prostate gland is enlarged. About 60% of men with BPH are treated
for lower urinary tract symptoms (LUTS).5,6 LUTS can be
divided into storage, voiding, and postmicturition
symptoms.7 Over half of men with BPH report storage
symptoms and about a quarter report voiding
symptoms.6 This suggests that many men with a
diagnosis of BPH may have overactive bladder.6 Many
men who are treated for symptoms are assumed to have an obstruction
in the bladder caused by an enlarged prostate.5,6 About
half of all men between ages 51 and 60 have BPH and up to 90% of
men over age 80 are living with the condition.1
INDICATIONS AND USAGE
GEMTESA is a beta-3
adrenergic agonist indicated for the treatment of overactive
bladder (OAB) with symptoms of urge urinary incontinence, urgency,
and urinary frequency in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
GEMTESA is contraindicated in patients
with known hypersensitivity to vibegron or any components of the
product.
WARNINGS AND PRECAUTIONS
Urinary Retention
Urinary retention has been reported in
patients taking GEMTESA. The risk of urinary retention may be
increased in patients with bladder outlet obstruction and also in
patients taking muscarinic antagonist medications for the treatment
of OAB. Monitor patients for signs and symptoms of urinary
retention, particularly in patients with bladder outlet obstruction
and patients taking muscarinic antagonist medications for the
treatment of OAB. Discontinue GEMTESA in patients who develop
urinary retention.
ADVERSE REACTIONS
Most common adverse reactions (≥2%)
reported with GEMTESA were headache, urinary tract infection,
nasopharyngitis, diarrhea, nausea, and upper respiratory tract
infection.
Please see full Prescribing
Information.
About Sumitomo Pharma
Sumitomo Pharma Co., Ltd. is a
global pharmaceutical company based in Japan with key operations in the U.S.
(Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and
Europe (Sumitomo Pharma
Switzerland GmbH) focused on addressing patient needs in oncology,
urology, women's health, rare diseases, psychiatry & neurology,
and cell & gene therapies. With several marketed products in
the U.S., Canada, and Europe, a diverse pipeline of early- to
late-stage assets, and in-house advanced technology capabilities,
we aim to accelerate discovery, research, and development to bring
novel therapies to patients sooner. For more information on SMPA,
visit our website https://www.us.sumitomo-pharma.com or
follow us on LinkedIn.
SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd.,
used under license.
Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo
Pharma Co., Ltd.
GEMTESA is a trademark of Urovant Sciences GmbH, and registered in
the U.S., and in other countries.
© 2024 Sumitomo Pharma America, Inc. All rights reserved.
|
For a copy of this
release, visit Sumitomo Pharma America's website
at www.us.sumitomo-pharma.com.
|
References
- Prostate Enlargement (Benign Prostatic Hyperplasia).
National Institute of Diabetes and Digestive and Kidney Diseases.
September 2014.
https://www.niddk.nih.gov/health-information/urologic-diseases/prostate-problems/prostate-enlargement-benign-prostatic-hyperplasia
- Herschorn S, McVary K, Santos J, Foley S, Kristy R, Choudhury
N, Hairston J, Kaplan S. Mirabegron Vs Placebo Add-on Therapy in
Men With Overactive Bladder Symptoms Receiving Tamsulosin for
Underlying Benign Prostatic Hyperplasia: A Safety Analysis From the
Randomized, Phase 4 PLUS Study. Urology, volume 147, p235-242,
January 2021. Published online 2020
October 09. doi: https://doi.org/10.1016/j.urology.2020.09.040
- Overactive bladder – symptoms and causes. Mayo Clinic. 2022.
Accessed August 25,
2023. https://www.mayoclinic.org/diseases-conditions/overactive-bladder/symptoms-causes/syc-20355715
- Gomelsky A. Update on the management of overactive bladder:
patient considerations and adherence. Journal of Urology. Open
Access J Urol. 2011; 3: 7–17. Published online 2010 Dec 30. doi:
10.2147/OAJU.S7233
- Burnett AL, Walker DR, Feng Q, Johnston KM, Lozano-Ortega
G, Nimke D, Hairston JC. Undertreatment of overactive bladder among
men with lower urinary tract symptoms in the United States: A retrospective observational
study. Neurourol Urodyn. 2020 Jun;39(5):1378-1386. doi:
10.1002/nau.24348. Epub 2020 May 8. PMID: 32383533; PMCID:
PMC7384148.
- Anger, JT, Goldman, HB, Luo, X, et
al. Patterns of medical management of overactive bladder (OAB)
and benign prostatic hyperplasia (BPH) in the United
States. Neurourology and
Urodynamics. 2018; 37: 213–222. https://doi.org/10.1002/nau.23276
- Lepor H. Pathophysiology of lower urinary tract symptoms
in the aging male population. Rev Urol. 2005;7 Suppl 7(Suppl
7):S3-S11. PMID: 16986059; PMCID: PMC1477625.
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