FDA approves supplemental new drug application (sNDA) for
Talicia, changing dosing to a simplified three times daily (TID)
regimen, which may support increased patient adherence and
treatment outcomes
Talicia is the leading branded first-line therapy prescribed
by U.S. gastroenterologists[1] for
eradication of H. pylori - a bacterial infection that affects
approximately 35% of the U.S. adult
population[2]
RALEIGH,
N.C. and TEL-AVIV,
Israel, Sept. 18, 2023 /PRNewswire/
-- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the
"Company"), a specialty biopharmaceutical company, announced the
U.S. Food and Drug Administration's (FDA) approval of its
supplemental new drug application (sNDA) for
Talicia[3], allowing a change to a more
flexible three times daily (TID), taken at least 4 hours apart with
food, dosing regimen for H. pylori eradication. This differs
from the previously approved dosing regimen (Q8H), which required
dosing every eight hours with food, by enabling patients to follow
a convenient "breakfast, lunch and dinner" dosing routine, which
may support increased patient adherence and optimize the potential
for successful H. pylori eradication.
"H. pylori treatment can be challenging for patients as
most regimens require different pills to be taken multiple times
per day. However, it is clear that simplified regimens promote
improved patient adherence and should be a key factor when
considering choice of H. pylori eradication therapy,"
said Colin W. Howden, MD,
Professor Emeritus, University of
Tennessee College of Medicine. "This new dosing regimen
further supports the value of Talicia as an empirically prescribed
first-line therapy for H. pylori eradication. Talicia's
favorable efficacy, tolerability, and resistance profile, as well
as being the only all-in-one formulation available, provides
potential advantages over clarithromycin-based regimens for most
patients."
"Talicia is unique in that it is the only FDA-approved
rifabutin-based therapy for the eradication of H. pylori.
Both its components and formulation are optimized to provide
patients with the necessary medications for successful H.
pylori eradication," said Dr. June
Almenoff, MD, Ph.D., RedHill's Chief Medical
Officer. "RedHill is committed to advancing GI and
infectious disease management through patient-focused innovation.
Through our successful collaboration with Certara, utilizing their
Simcyp™ Simulator for physiologically based pharmacokinetic (PBPK)
modeling, we have demonstrated therapeutic equivalence between TID
and Q8H dosing, enabling us to provide what we believe is a
more flexible Talicia regimen that we believe will be beneficial
for the patient experience."
About H. pylori
infection
H. pylori is
a bacterial infection that affects approximately 35% of the U.S.
population, with an estimated two million patients treated
annually[4]. Worldwide, more than 50% of the
population has H. pylori infection, which is classified by
the WHO as a Group 1 carcinogen. It remains the strongest known
risk factor for gastric cancer[5] and a
major risk factor for peptic ulcer
disease[6] and gastric mucosa-associated
lymphoid tissue (MALT) lymphoma[7]. More than
27,000 Americans are diagnosed with gastric cancer
annually[8]. Eradication of H.
pylori is becoming increasingly difficult, with current
therapies failing in approximately 25-40% of patients who
remain H. pylori-positive due to high resistance
of H. pylori to antibiotics – especially
clarithromycin – which is still commonly used in standard
combination therapies2.
About Talicia
Talicia is a novel, fixed-dose,
all-in-one oral capsule combination of two antibiotics (amoxicillin
and rifabutin) and a proton pump inhibitor (PPI) (omeprazole),
approved by the U.S. FDA for the treatment of H. pylori
infection in adults.
Talicia is the only low-dose rifabutin-based therapy approved
for the treatment of H. pylori infection and is designed to
address H. pylori's high resistance to other antibiotics.
The high rates of H. pylori resistance to clarithromycin
have led to significant rates of treatment failure with
clarithromycin-based therapies and are a strong public health
concern, as highlighted by the ACG, FDA and the World Health
Organization (WHO) in recent years.
In the pivotal Phase 3 study, Talicia demonstrated 84%
eradication of H. pylori infection in the intent-to-treat
(ITT) group vs. 58% in the active comparator arm (p<0.0001).
Minimal to zero resistance to rifabutin, a key component of
Talicia, was detected in RedHill's pivotal Phase 3 study. Further,
in an analysis of data from this study, it was observed that
subjects who were confirmed adherent[9] to
their therapy had response rates of 90.3% in the Talicia arm vs.
64.7% in the active comparator arm[10]. To
reduce the development of drug-resistant bacteria and maintain the
effectiveness of Talicia and other antibacterial drugs, Talicia
should be used only to treat or prevent infections that are proven
or strongly suspected to be caused by bacteria.
Talicia is eligible for a total of eight years of U.S. market
exclusivity under its Qualified Infectious Disease Product (QIDP)
designation and is also covered by U.S. patents which extend patent
protection until 2034 with additional patents and applications
pending and granted in various territories worldwide.
TALICIA: IMPORTANT SAFETY INFORMATION
Tell your healthcare provider about all of the medicines you
take, including prescription or non-prescription medications or
herbal supplements before starting Talicia. Talicia may affect the
way other medicines work, and other medicines may affect the way
Talicia works. Do not start any new medications while taking
Talicia without first speaking with your healthcare provider.
- You should not take Talicia if you are known to be
sensitive to any of the components of Talicia (omeprazole,
amoxicillin, rifabutin), penicillins, proton pump inhibitors or
rifamycins.
- You should not take Talicia if you are taking
rilpivirine-containing products, delavirdine or voriconazole.
Before you take Talicia, tell your healthcare provider about
all of your medical conditions, including if you:
- Are pregnant or plan to become pregnant. Talicia may harm
your unborn baby. Tell your healthcare provider if you become
pregnant or think you may be pregnant during your treatment with
Talicia.
- Have severe kidney disease or liver disease.
When taking Talicia, do not crush or chew capsules. Do not
take Talicia with alcohol.
Call your healthcare provider immediately if while taking
Talicia you develop:
- New rash or other skin changes, muscle or joint pains, swelling
of any area of the body, severe flu-like symptoms, difficulty
breathing, fever, blood in your urine, increased or decreased
urination, drowsiness, confusion, nausea, vomiting, ongoing stomach
pain, bloody diarrhea, or if diarrhea continues after therapy is
completed, weight gain or changes in your eyesight.
What are the common side effects of Talicia?
- The most common side effects of Talicia are diarrhea,
headache, nausea, stomach pain, rash, indigestion, mouth or throat
pain, vomiting, and vaginal yeast infection. Call your healthcare
professional for medical advice about side effects.
- Tell your healthcare provider if you experience tiredness,
weakness, achiness, headaches, dizziness, depression,
increased sensitivity to light, or pain when taking a deep
breath.
- Talicia may reduce the effectiveness of oral or other
forms of hormonal birth-control. You should use an additional
non-hormonal highly effective method of birth control while
taking Talicia.
- You may experience a brown-orange discoloration of your urine
or tears while taking Talicia.
- The information here is not comprehensive. Talk to your
healthcare provider to learn more.
APPROVED USE FOR TALICIA
TALICIA is indicated for the treatment of Helicobacter
pylori infection in adults.
Click here for the full Prescribing Information for
TALICIA.
You are encouraged to report Adverse Reactions to RedHill
Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty
biopharmaceutical company primarily focused on gastrointestinal and
infectious diseases. RedHill promotes the gastrointestinal drugs
Talicia®, for the treatment of Helicobacter
pylori (H. pylori) infection in
adults[11], and Aemcolo®,
for the treatment of travelers' diarrhea in
adults[12]. RedHill's key clinical late-stage
development programs include: (i) opaganib (ABC294640),
a first-in-class oral broad-acting, host-directed
SPHK2 selective inhibitor with potential for pandemic preparedness,
targeting multiple indications with a U.S. Government collaboration
for development for Acute Radiation Syndrome (ARS), a Phase 2/3
program for hospitalized COVID-19, and a Phase 2 program in
oncology; (ii) RHB-107 (upamostat), an oral
broad-acting, host-directed, serine protease inhibitor with
potential for pandemic preparedness is in late-stage development as
a treatment for non-hospitalized symptomatic COVID-19, and is also
targeting multiple other cancer and inflammatory gastrointestinal
diseases; (iii) RHB-102, with potential UK submission
for chemotherapy and radiotherapy induced nausea and vomiting,
positive results from a Phase 3 study for acute gastroenteritis and
gastritis and positive results from a Phase 2 study for IBS-D;
(iv) RHB-104, with positive results from a first Phase
3 study for Crohn's disease; and (v) RHB-204, a
Phase 3-stage program for pulmonary nontuberculous mycobacteria
(NTM) disease.
More information about the Company is available at:
www.redhillbio.com / twitter.com/RedHillBio.
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements may be preceded by the words "intends,"
"may," "will," "plans," "expects," "anticipates," "projects,"
"predicts," "estimates," "aims," "believes," "hopes," "potential"
or similar words. Forward-looking statements are based on certain
assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company's control and
cannot be predicted or quantified, and consequently, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties, including
without limitation the risk that the Company will not succeed to
expand Talicia's reach to additional ex-U.S. territories; as well
as other risk and uncertainties associated with (i) the initiation,
timing, progress and results of the Company's research,
manufacturing, pre-clinical studies, clinical trials, and other
therapeutic candidate development efforts, and the timing of the
commercial launch of its commercial products and ones it may
acquire or develop in the future; (ii) the Company's ability to
advance its therapeutic candidates into clinical trials or to
successfully complete its pre-clinical studies or clinical trials;
(iii) the extent and number and type of additional studies that the
Company may be required to conduct and the Company's receipt of
regulatory approvals for its therapeutic candidates, and the timing
of other regulatory filings, approvals and feedback; (iv) the
manufacturing, clinical development, commercialization, and market
acceptance of the Company's therapeutic candidates and
Talicia®; (v) the Company's ability to successfully
commercialize and promote Talicia® and
Aemcolo®; (vi) the Company's ability to establish and
maintain corporate collaborations; (vii) the Company's ability to
acquire products approved for marketing in the U.S. that achieve
commercial success and build its own marketing and
commercialization capabilities; (viii) the interpretation of the
properties and characteristics of the Company's therapeutic
candidates and the results obtained with its therapeutic candidates
in research, pre-clinical studies or clinical trials; (ix) the
implementation of the Company's business model, strategic plans for
its business and therapeutic candidates; (x) the scope of
protection the Company is able to establish and maintain for
intellectual property rights covering its therapeutic candidates
and its ability to operate its business without infringing the
intellectual property rights of others; (xi) parties from whom the
Company licenses its intellectual property defaulting in their
obligations to the Company; (xii) estimates of the Company's
expenses, future revenues, capital requirements and needs for
additional financing; (xiii) the effect of patients suffering
adverse experiences using investigative drugs under the Company's
Expanded Access Program; and (xiv) competition from other companies
and technologies within the Company's industry. More detailed
information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the
Company's filings with the Securities and Exchange Commission
(SEC), including the Company's Annual Report on Form 20-F filed
with the SEC on April 28, 2023. All forward-looking statements
included in this press release are made only as of the date of this
press release. The Company assumes no obligation to update any
written or oral forward-looking statement, whether as a result of
new information, future events or otherwise unless required by
law.
Company
contact:
Adi Frish
Chief Corporate &
Business Development Officer
RedHill
Biopharma
+972-54-6543-112
adi@redhillbio.com
|
|
Category: Commercial
[1] IQVIA XPO Data on file
[2] Hooi JKY et al. Global Prevalence of Helicobacter
pylori Infection: Systematic Review and Meta-Analysis.
Gastroenterology 2017; 153:420-429.
[3] Talicia® (omeprazole magnesium, amoxicillin and
rifabutin) is indicated for the treatment of H. pylori infection in
adults. For full prescribing information see: www.Talicia.com.
[4] IQVIA Custom Study for RedHill Biopharma, 2019
[5] Lamb A et al. Role of the Helicobacter pylori–Induced
inflammatory response in the development of gastric cancer. J Cell
Biochem 2013;114.3:491-497.
[6] NIH – Helicobacter pylori and Cancer, September
2013.
[7] Hu Q et al. Gastric mucosa-associated lymphoid tissue
lymphoma and Helicobacter pylori infection: a review of
current diagnosis and management. Biomarker research
2016;4.1:15.
[8] National Cancer Institute, Surveillance, Epidemiology, and
End Results Program (SEER).
[9] Defined as the PK population which included those subjects
in the ITT population who had demonstrated presence of any
component of investigational drug at visit 3 (approx. day 13) or
had undetected levels drawn >250 hours after the last dose.
[10] The pivotal Phase 3 study with Talicia®
demonstrated 84% eradication of H. pylori infection with
Talicia® vs. 58% in the active comparator arm (ITT
analysis, p<0.0001).
[11] Talicia® (omeprazole magnesium, amoxicillin
and rifabutin) is indicated for the treatment of H. pylori
infection in adults. For full prescribing information see:
www.Talicia.com.
[12] Aemcolo® (rifamycin) is indicated for the
treatment of travelers' diarrhea caused by noninvasive strains of
Escherichia coli in adults. For full prescribing information
see: www.aemcolo.com.
Logo -
https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/redhill-announces-fda-snda-approval-for-talicia-301930308.html
SOURCE RedHill Biopharma Ltd.