DUBLIN, Jan. 5, 2024
/PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) today
announced results from the Phase 4 PIFR-2 study of
YUPELRI® (revefenacin) inhalation solution, the only
once-daily, nebulized long-acting muscarinic antagonist (LAMA)
approved in the U.S. for maintenance treatment of COPD.
The PIFR-2 study aimed to demonstrate greater improvement in
lung function for YUPELRI delivered via standard jet nebulizer
compared to Spiriva® (tiotropium) delivered via a dry
powder inhaler (Spiriva® HandiHaler®) in
adults with severe to very severe COPD and suboptimal peak
inspiratory flow rate (PIFR).
- The study did not show a statistically significant difference
between YUPELRI and Spiriva HandiHaler on the primary endpoint,
change from baseline in trough forced expiratory volume in one
second (FEV1) at Day 85.
- Similar lung function improvement was demonstrated in both arms
of the study.
- YUPELRI demonstrated safety and tolerability consistent with
its profile in previous clinical studies.
Chief Executive Officer Rick E Winningham said: "While the
primary endpoint in the Phase 4 PIFR-2 study was not met, YUPELRI
demonstrated an efficacy and safety profile consistent with its
performance in other clinical studies. We appreciate the growth
opportunities that lie ahead for YUPELRI, which is an important
option for COPD maintenance care, and look forward to sharing
additional details from PIFR-2 in the future, following additional
data analyses."
About the PIFR-2 Study
The Phase 4 PIFR-2 Study (NCT05165485) is a
randomized, double-blind, parallel-group study, comparing
improvements in lung function in adults with severe to very severe
COPD (FEV1 <50% of predicted) and suboptimal PIFR
(<55 L/min) following once-daily treatment over 12 weeks with
either YUPELRI (revefenacin) inhalation solution delivered via
standard jet nebulizer or Spiriva (tiotropium) delivered via a dry
powder inhaler (Spiriva HandiHaler). YUPELRI is approved in the
U.S. for the maintenance treatment of patients with COPD; Spiriva
HandiHaler is approved in the U.S. for the long-term, once-daily,
maintenance treatment of bronchospasm associated with COPD, and for
reducing COPD exacerbations.
About YUPELRI®
YUPELRI® (revefenacin) inhalation solution is a
once-daily nebulized long-acting muscarinic antagonist (LAMA)
approved for the maintenance treatment of COPD in the U.S. LAMAs
are recognized by international COPD treatment guidelines as a
cornerstone of maintenance therapy for COPD, regardless of severity
of disease. Our market research indicates there is an enduring
population of COPD patients in the U.S. that either need or prefer
nebulized delivery for maintenance therapy. The stability of
revefenacin in both metered dose inhaler and dry powder inhaler
("MDI/DPI") formulations suggests that revefenacin could also serve
as a foundation for novel handheld combination products.
Important Safety Information
What is YUPELRI®?
- YUPELRI is a prescription medicine used to treat chronic
obstructive pulmonary disease (COPD), a long-term (chronic) lung
disease that includes chronic bronchitis, emphysema, or both.
- It is an anticholinergic medicine which helps the muscles
around the airway in your lungs stay relaxed to prevent symptoms
such as wheezing, cough, chest tightness, and shortness of
breath.
- It is used long-term as 1 vial of YUPELRI, 1 time each day
inhaled through your nebulizer to improve symptoms of COPD for
better breathing.
Who should not use YUPELRI?
- Do not use YUPELRI if you have sudden breathing
problems. Always have a rescue inhaler with you.
- Do not use YUPELRI if you have had an allergic
reaction to revefenacin, or any of the other ingredients in YUPELRI
(sodium chloride, citric acid, sodium citrate).
- Do not use in children. It is not known if YUPELRI is safe and
effective in children.
Before using YUPELRI, tell your healthcare provider about all
your medical conditions, including if you:
- have eye problems such as glaucoma. YUPELRI may make your
glaucoma worse.
- have prostate or bladder problems, or problems passing urine.
YUPELRI may make these problems worse.
- have liver problems.
- are allergic to any of the ingredients in YUPELRI, or any
other medicines.
- are pregnant or planning to become pregnant. It is not known
if YUPELRI may harm your unborn baby.
- are breastfeeding. It is not known if the medicine in
YUPELRI passes into your breast milk and if it can harm your
baby.
Tell your healthcare provider about all the medicines you
take including prescription and over-the-counter
medicines, vitamins, and herbal supplements. YUPELRI and certain
other medicines may interact with each other. This may cause
serious side effects.
Especially tell your healthcare provider if you take:
- Other anticholinergics (including tiotropium, ipratropium,
aclidinium, umeclidinium, glycopyrrolate)
- Atropine
Know the medicines you take. Keep a list of them to show your
healthcare provider and pharmacist each time you get a new
medicine.
What are the possible side effects with YUPELRI?
YUPELRI can cause serious side effects, including:
- Sudden breathing problems immediately after inhaling your
medicine. If you have sudden breathing problems
immediately after inhaling your medicine, stop using YUPELRI and
call your healthcare provider right away.
- New or worsened eye problems including acute narrow-angle
glaucoma. Acute narrow-angle glaucoma can cause permanent
loss of vision if not treated. Symptoms may include:
- Red eyes
- Blurred vision
- Seeing halos or bright colors around lights
- Eye pain or discomfort
- Nausea or vomiting
- Urinary retention. People who take YUPELRI may
develop new or worse urinary retention. Symptoms of urinary
retention may include:
- difficulty urinating
- urinating frequently
- urination in a weak stream or drips
- painful urination
If you have any of these symptoms, call your healthcare provider
right away before taking another dose.
- Serious allergic reactions. Call your healthcare
provider or get emergency medical care if you get any of the
following symptoms of a serious allergic reaction:
- rash
- hives
- severe itching
- swelling of your face, mouth, and tongue
- difficulty breathing or swallowing
If you have any of these symptoms, stop taking YUPELRI, and call
your healthcare provider right away before taking another dose.
- Common side effects of YUPELRI include:
- Cough
- Runny nose
- Upper respiratory tract infection
- Headache
- Back pain
Tell your healthcare provider if you get any side effects that
bother you or that do not go away. These are not all the possible
side effects with YUPELRI. Ask your healthcare provider or
pharmacist for more information. Call your doctor for medical
advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
How should I use YUPELRI?
Read the step by step instructions for using YUPELRI in the
FDA-approved Prescribing Information and at the end of this Patient
Information Leaflet
- YUPELRI is only for use with a nebulizer.
- Do not use YUPELRI more often than prescribed.
- Do not mix YUPELRI with other medicines in your
nebulizer.
- Do not use other medicines that contain
an anticholinergic for any reason.
- Do not stop using YUPELRI, even if you are feeling
better, unless your healthcare provider tells you to because your
symptoms might get worse.
- Call your healthcare provider or get emergency medical care
right away if
- your breathing problems get worse.
- you need to use your rescue inhaler medicine more often than
usual.
- your rescue inhaler medicine does not relieve your
symptoms.
This summary does not include all the information about
YUPELRI and is not meant to take the place of a discussion with
your healthcare provider about your treatment.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliver Medicines that
Make a Difference® in people's lives. In pursuit of its
purpose, Theravance Biopharma leverages decades of expertise, which
has led to the development of FDA-approved YUPELRI®
(revefenacin) inhalation solution indicated for the maintenance
treatment of patients with chronic obstructive pulmonary disease
(COPD). Ampreloxetine, its late-stage investigational
norepinephrine reuptake inhibitor in development for symptomatic
neurogenic orthostatic hypotension, has the potential to be a first
in class therapy effective in treating a constellation of cardinal
symptoms in multiple system atrophy patients. The Company is
committed to creating/driving shareholder value.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE®, and
the Cross/Star logo are registered trademarks of the Theravance
Biopharma group of companies (in the U.S. and certain other
countries). YUPELRI® is a registered trademark of Mylan
Specialty L.P., a Viatris company. Trademarks, trade names or
service marks of other companies appearing on this press release
are the property of their respective owners.
About Theravance Biopharma / Viatris Collaboration
Theravance Biopharma and Viatris Inc. and their respective
affiliates have established a strategic collaboration to develop
and commercialize nebulized revefenacin products for COPD.
Theravance Biopharma Forward-Looking Statements
This press release contains certain "forward-looking" statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995 regarding, among other things, statements relating to
goals, plans, objectives, expectations and future events.
Theravance Biopharma intends such forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 21E of the Securities Exchange Act
of 1934, as amended, and the Private Securities Litigation Reform
Act of 1995. Examples of such statements include statements
relating to: future YUPELRI sales and sales growth, timing of
additional details from PIFR-2, and the ability to provide
value to shareholders, the Company's regulatory strategies and
timing of clinical studies, and possible safety, efficacy or
differentiation of our investigational therapy. These statements
are based on the current estimates and assumptions of the
management of Theravance Biopharma as of the date of this press
release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the
actual results of Theravance Biopharma to be materially different
from those reflected in the forward-looking statements. Important
factors that could cause actual results to differ materially from
those indicated by such forward-looking statements include, among
others, risks related to: whether the milestone thresholds can be
achieved, delays or difficulties in commencing, enrolling or
completing clinical studies, the potential that results from
clinical or non-clinical studies indicate the Company's product
candidates or product are unsafe, ineffective or not
differentiated, risks of decisions from regulatory authorities that
are unfavorable to the Company, dependence on third parties to
conduct clinical studies, delays or failure to achieve and maintain
regulatory approvals for product candidates, risks of collaborating
with or relying on third parties to discover, develop, manufacture
and commercialize products, and risks associated with establishing
and maintaining sales, marketing and distribution capabilities with
appropriate technical expertise and supporting infrastructure,
ability to retain key personnel, the ability of the Company to
protect and to enforce its intellectual property rights, volatility
and fluctuations in the trading price and volume of the Company's
shares, and general economic and market conditions. Other risks
affecting Theravance Biopharma are in the Company's Form 10-Q filed
with the SEC on November 9, 2023, and
other periodic reports filed with the SEC. In addition to the risks
described above and in Theravance Biopharma's filings with the SEC,
other unknown or unpredictable factors also could affect Theravance
Biopharma's results. No forward-looking statements can be
guaranteed, and actual results may differ materially from such
statements. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Theravance Biopharma
assumes no obligation to update its forward-looking statements on
account of new information, future events or otherwise, except as
required by law.
Theravance Biopharma Contact:
investor.relations@theravance.com
650-808-4045
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SOURCE Theravance Biopharma, Inc.