- Data from the 12-week EMPOWUR trial regarding patient
perceptions of improvement of OAB symptoms show that significantly
more patients treated once-daily with GEMTESA® (vibegron)
experienced patient-perceived improvements due to the reduction in
micturition frequency (urination), urinary urgency episodes, and
urge urinary incontinence episodes vs. placebo.
- This analysis supports that the statistically significant
reductions in clinical endpoints seen in the EMPOWUR trial are
meaningful to patients.
Urovant Sciences, Inc., a wholly-owned subsidiary of Sumitovant
Biopharma Ltd., announced today that the journal Advances in
Therapy has published patient-perception data supporting clinical
meaningfulness of overactive bladder (OAB) symptom reduction for
its FDA-approved OAB therapy, GEMTESA® (vibegron), compared to
placebo. The article entitled, “Interpretation of the
Meaningfulness of Symptom Reduction with Vibegron in Patients with
Overactive Bladder: Analyses from EMPOWUR” is available online and
the print version will be published in an upcoming issue of the
journal.
The analysis of 12-week data from the EMPOWUR study regarding
patient perception supports that the reductions in OAB symptoms
such as urinary frequency, urgency, and urinary incontinence were
meaningful to patients after treatment with GEMTESA 75 mg compared
with those receiving placebo. These data also were presented at
sectional American Urological Association (AUA) and Urology-focused
meetings this fall including SCS-AUA, NCS-AUA, ICS, NE-AUA, SUNA,
and WS-AUA.
“Our findings suggest that the statistically significant
improvements in bothersome symptoms of OAB seen in the 12-week
EMPOWUR trial are indeed clinically relevant in terms of patient
perceptions,” said lead author Jeffrey Frankel, MD, of Seattle
Urology Research Center. “These significantly higher proportions of
patients achieving pre-defined patient-perceived symptom
improvements are likely to inform patients and providers in
establishing realistic treatment goals.”
“The patient-centered analysis further supports that GEMTESA is
an important treatment option with meaningful clinical benefit for
patients with OAB,” said Cornelia Haag-Molkenteller, MD, PhD,
executive vice president and Chief Medical Officer of Urovant
Sciences. “The publication in a peer-reviewed journal is another
example of Urovant’s commitment to informing the scientific –
medical community about meaningful effects of GEMTESA.”
About the Analysis
Although OAB is highly prevalent among adults; large clinical
studies often neglect to report patient perceptions of the
meaningfulness of symptom improvement. The new publication
describes a method to derive meaningful within-patient change using
a patient-reported measure, the Patient Global Impression of Change
(PGI-C). Based on patient interviews and PGI-C results applied to
phase 2 and 3 studies, the authors established responder-based
definitions of clinically meaningful improvement in reducing
micturitions, urgency episodes, and UUI episodes. This analysis
indicated that significantly more patients receiving vibegron vs.
placebo achieved meaningful responder definitions: ≥15 percent
reduction in micturitions (56.3 vs. 44.6 percent, respectively)
(post hoc), ≥50 percent reduction in urgency episodes (39.5 vs.
32.8 percent), ≥75 percent reduction in UUI episodes (49.3 vs. 32.8
percent), and ≥90 percent reduction in UUI episodes (35.2 vs. 23.5
percent) (post hoc) at week 12 (P<0.05 each).
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), frequent
urination (usually eight or more times in 24 hours), and nocturia
(waking up more than two times in the night to urinate).1
Approximately 30 million Americans suffer from bothersome
symptoms of OAB, which can have a significant impairment on a
patient’s day-to-day activities.1, 2
About GEMTESA®
GEMTESA is a prescription medicine for adults used to treat the
following symptoms due to a condition called overactive
bladder:
- urge urinary incontinence: a strong need to urinate with
leaking or wetting accidents
- urgency: the need to urinate right away
- frequency: urinating often
It is not known if GEMTESA is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
Do not take GEMTESA if you are allergic to vibegron or
any of the ingredients in GEMTESA.
Before you take GEMTESA, tell your doctor about all your
medical conditions, including if you have liver problems; have
kidney problems; have trouble emptying your bladder or you have a
weak urine stream; take medicines that contain digoxin; are
pregnant or plan to become pregnant (it is not known if GEMTESA
will harm your unborn baby; talk to your doctor if you are pregnant
or plan to become pregnant); are breastfeeding or plan to
breastfeed (it is not known if GEMTESA passes into your breast
milk; talk to your doctor about the best way to feed your baby if
you take GEMTESA).
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. Know the medicines you take. Keep a list of
them to show your doctor and pharmacist when you get a new
medicine.
What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability
to empty your bladder (urinary retention). GEMTESA may increase
your chances of not being able to empty your bladder, especially if
you have bladder outlet obstruction or take other medicines for
treatment of overactive bladder. Tell your doctor right away if you
are unable to empty your bladder.
The most common side effects of GEMTESA include headache,
urinary tract infection, nasal congestion, sore throat or runny
nose, diarrhea, nausea, and upper respiratory tract infection.
These are not all the possible side effects of GEMTESA. For more
information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.
Please click here for full Product Information
for GEMTESA.
About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on
developing and commercializing innovative therapies for areas of
unmet need, with a dedicated focus in Urology. The Company’s lead
product, GEMTESA®(vibegron), is an oral, once-daily (75 mg) small
molecule beta-3 agonist for the treatment of adult patients with
overactive bladder (OAB) with symptoms of urge urinary
incontinence, urgency, and urinary frequency. GEMTESA was approved
by the U.S. FDA in December 2020 and launched in the U.S. in April
2021. GEMTESA is also being evaluated for the treatment of OAB in
men with benign prostatic hyperplasia. The Company’s second product
candidate, URO-902, is a novel gene therapy being developed for
patients with OAB who have failed oral pharmacologic therapy.
Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma
Ltd., intends to bring innovation to patients in need in urology
and other areas of unmet need. Learn more about us at
www.urovant.com.
About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging
data-driven insights to rapidly accelerate development of new
potential therapies for unmet patient conditions. Through our
unique portfolio of wholly-owned “Vant” subsidiaries—Urovant,
Enzyvant, Spirovant, Altavant—and use of embedded computational
technology platforms to generate business and scientific insights,
Sumitovant has supported the development of FDA-approved products
and advanced a promising pipeline of early-through late-stage
investigational assets for other serious conditions. Sumitovant, a
wholly-owned subsidiary of Sumitomo Dainippon Pharma, is also the
majority-shareholder of Myovant (NYSE: MYOV). For more information,
please visit our website at www.sumitovant.com or follow us on
Twitter and LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed
pharmaceutical companies in Japan, operating globally in major
pharmaceutical markets, including Japan, the U.S., China, and other
Asian countries. Sumitomo Dainippon Pharma is based on the 2005
merger between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more
than 7,000 employees worldwide. Additional information about
Sumitomo Dainippon Pharma is available through its corporate
website at https://www.ds-pharma.com.
To read our news release, visit urovant.com/news-releases.
- Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The
Burden of Overactive Bladder on US Public Health. Current bladder
dysfunction reports, 11(1), 8–13.
https://doi.org/10.1007/s11884-016-0344-9
- Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z.
S., & Milsom, I. (2011). National community prevalence of
overactive bladder in the United States stratified by sex and age.
Urology, 77(5), 1081–1087.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211220005599/en/
Urovant Sciences Alana Darden Powell Vice President, Corporate
Communications 949-436-3116 alana.darden@Urovant.com
media@urovant.com Sumitovant Biopharma Maya Frutiger Vice
President, Corporate Communications media@sumitovant.com
Urovant Sciences (NASDAQ:UROV)
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