- XACDURO is a new FDA-approved treatment used to fight against
HABP/VABP infections caused by isolates of Acinetobacter
baumannii-calcoaceticus complex, which can include those resistant
to carbapenems (CRAB).
- In the U.S., it is estimated there are more than 40,000 cases
of Acinetobacter each year and approximately 40 percent are
carbapenem-resistant.1,2
- Patients with HABP/VABP caused by Acinetobacter infections face
high mortality and significant costs due to drug resistance and
limited approved treatment options.
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc.
(Nasdaq: INVA), today announced that XACDURO®
(sulbactam for injection; durlobactam for injection) is now
available in the United States for patients 18 years of age and
older for the treatment of hospital-acquired bacterial pneumonia
and ventilator-associated bacterial pneumonia (HABP/VABP) caused by
susceptible isolates of Acinetobacter baumannii-calcoaceticus
complex (Acinetobacter).
“XACDURO’s pathogen-targeted approach is a significant
advancement in the way healthcare professionals treat
Acinetobacter, one of the most serious antibiotic-resistant
pathogens known to cause life-threatening pneumonia that is
associated with high morbidity and mortality rates,” said Pavel
Raifeld, Chief Executive Officer, Innoviva. “The addition of
XACDURO to our portfolio of critical care medicines underscores our
commitment to this space by providing healthcare professionals with
differentiated therapeutic options to help improve patient
outcomes.”
XACDURO received regulatory approval from the U.S. Food and Drug
Administration (FDA) in May 2023 and is now available by
prescription through specialty pharmacy distributors in a
healthcare setting. The FDA approval was based on strong scientific
evidence, including results from the landmark Phase 3 ATTACK trial,
published in The Lancet: Infectious Disease, evaluating the safety
and efficacy of XACDURO versus colistin in patients with infections
caused by Acinetobacter.3 In the trial, XACDURO demonstrated
statistical non-inferiority versus colistin for the primary
endpoint of 28-day all-cause mortality in patients with
carbapenem-resistant Acinetobacter infections and a significant
difference in clinical cure rates.3 XACDURO was well tolerated and
exhibited a favorable safety profile across the clinical program.
In clinical studies, XACDURO was shown to significantly lower the
incidence of nephrotoxicity.3 Fewer serious adverse events were
observed compared to treatment with colistin, and there was lower
treatment discontinuation due to adverse reactions versus colistin
with one patient experiencing anaphylactic shock, which lead to
discontinuation of treatment for that patient.3
Acinetobacter infections are now the fifth most common cause of
deaths attributable to drug resistance across the globe and pose
greatest threat to patients on ventilators in hospitals and nursing
homes. The Acinetobacter pathogen has become resistant to most
antibiotics used to treat HABP and VABP including carbapenems and
third generation cephalosporins. This has caused Acinetobacter to
become increasingly difficult to treat with no clear standard of
care antibiotic regimen for these resistant infections.
“Every minute matters when managing critical care patients with
life-threatening pneumonia, especially when caused by
carbapenem-resistant Acinetobacter baumannii pathogen.
Antibiotic-resistant pathogens can complicate treatment strategies
and compromise treatment efficacy, often resulting in increased
mortality rates for intensive care unit patients,” said Margaret
Koziel, MD, Chief Medical Officer, Innoviva. “Other treatment
options may have high rates of resistance and adverse events,
including nephrotoxicity.4 The availability of XACDURO is a
much-needed advancement that can now provide healthcare
professionals with an innovative therapy option to safely and
effectively manage Acinetobacter pneumonia.”
About Acinetobacter Members of the Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative,
opportunistic human pathogens that predominantly infect critically
ill patients, often resulting in severe pneumonia and bloodstream
infections.5 They can infect other body sites, such as the urinary
tract and the skin.5 Acinetobacter is considered a global threat in
the healthcare setting due in part to its ability to acquire
multidrug resistance.6 Acinetobacter is resistant to penicillins
and has also acquired resistance genes for almost all antibiotics
used to treat Gram-negative bacteria, including fluoroquinolones,
aminoglycosides, cephalosporins, and carbapenems.6
The Centers for Disease Control and Prevention (CDC) has
identified carbapenem-resistant micro-organisms as an urgent
threat.7 Globally, Acinetobacter baumannii was among the top six
leading pathogens for deaths associated with resistance in 2019.8
Carbapenem-resistant Acinetobacter is considered a Priority 1
pathogen by the World Health Organization (WHO).9 Globally, there
are about a million cases each year of Acinetobacter, and about
two-thirds of those are carbapenem-resistant Acinetobacter
baumannii.1 More than 300,000 global deaths annually are associated
with carbapenem-resistant Acinetobacter.8
About XACDURO® XACDURO® (sulbactam for injection;
durlobactam for injection), co-packaged for intravenous use, is a
combination of sulbactam, a beta-lactam antibacterial, and
durlobactam, a beta-lactamase inhibitor, approved in patients 18
years of age and older for the treatment of hospital-acquired
bacterial pneumonia and ventilator-associated bacterial pneumonia
(HABP/VABP) caused by susceptible isolates of Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter). XACDURO is not
indicated for the treatment of HABP/VABP caused by pathogens other
than susceptible isolates of Acinetobacter.
XACDURO® INDICATION & USAGE
Indication XACDURO® (sulbactam for injection; durlobactam
for injection), co-packaged for intravenous use is indicated in
adults for the treatment of hospital-acquired bacterial pneumonia
and ventilator-associated bacterial pneumonia (HABP/VABP) caused by
susceptible isolates of Acinetobacter baumannii-calcoaceticus
complex.
Limitations of Use XACDURO is not
indicated for the treatment of HABP/VABP caused by pathogens other
than susceptible isolates of Acinetobacter baumannii-calcoaceticus
complex.
Usage To reduce the development of drug-resistant
bacteria and maintain the effectiveness of XACDURO and other
antibacterial drugs, XACDURO should be used only to treat or
prevent infections that are proven or strongly suspected to be
caused by bacteria.
IMPORTANT SAFETY INFORMATION
Contraindications: XACDURO is contraindicated in patients
with a history of known severe hypersensitivity to the components
of XACDURO or other beta-lactam antibacterial drugs.
Warnings and Precautions:
- Hypersensitivity was observed in patients treated with XACDURO
in clinical trials. Serious and occasionally fatal hypersensitivity
(anaphylactic) reactions and serious skin reactions have been
reported in patients receiving beta-lactam antibacterial drugs.
Before initiating therapy with XACDURO, careful inquiry should be
made concerning previous hypersensitivity reactions to carbapenems,
penicillins, cephalosporins, other beta lactams, and other
allergens. If an allergic reaction occurs, discontinue
XACDURO.
- Clostridioides difficile-associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis. Evaluate if
diarrhea occurs. If CDAD is suspected or confirmed, the
risk/benefit of continuing treatment with XACDURO should be
assessed.
- Prescribing XACDURO in the absence of a proven or strongly
suspected bacterial infection or a prophylactic indication is
unlikely to provide benefit to the patient and increases the risk
of the development of drug-resistant bacteria.
Adverse Reactions: The most common adverse reactions
reported in >10% of patients treated with XACDURO were liver
test abnormalities (19%), diarrhea (17%), anemia (13%), and
hypokalemia (12%).
To report SUSPECTED ADVERSE REACTIONS, contact Innoviva
Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Before administering, please see the Full Prescribing
Information for XACDURO.
About Innoviva Specialty Therapeutics Innoviva Specialty
Therapeutics, a subsidiary of Innoviva, Inc., is focused on
delivering innovative therapies in critical care and infectious
disease. Innoviva Specialty Therapeutics’ products, through its
affiliate, La Jolla Pharmaceutical Company, include GIAPREZA®
(angiotensin II), approved to increase blood pressure in adults
with septic or other distributive shock, and XERAVA® (eravacycline)
for the treatment of complicated intra-abdominal infections in
adults. Innoviva Specialty Therapeutics’ products, through its
affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam
for injection; durlobactam for injection), co-packaged for
intravenous use approved for the treatment of adults with
hospital-acquired bacterial pneumonia and ventilator-associated
bacterial pneumonia caused by susceptible strains of Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter). For more
information about Innoviva Specialty Therapeutics, please visit
here.
About Innoviva Innoviva, Inc., is a diversified holding
company with a portfolio of royalties and other healthcare assets,
including Innoviva Specialty Therapeutics, a subsidiary focused on
delivering innovative therapies in critical care and infectious
disease. Innoviva’s royalty portfolio includes respiratory assets
partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO®
ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO®
ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the
Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva
is entitled to receive royalties from GSK on sales of RELVAR®/BREO®
ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR® and BREO® are
trademarks of the GSK group of companies. For more information on
Innoviva, please visit here.
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, and
future events. Innoviva 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 and the Private Securities Litigation Reform Act of 1995.
The words “anticipate”, “expect”, “goal”, “intend”, “objective”,
“opportunity”, “plan”, “potential”, “target” and similar
expressions are intended to identify such forward-looking
statements. Such forward-looking statements involve substantial
risks, uncertainties, and assumptions. These statements are based
on the current estimates and assumptions of the management of
Innoviva as of the date of this press release and are subject to
known and unknown risks, uncertainties, changes in circumstances,
assumptions and other factors that may cause the actual results of
Innoviva 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:
expected cost savings; lower than expected future royalty revenue
from respiratory products partnered with GSK; the commercialization
of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY®
ELLIPTA® in the jurisdictions in which these products have been
approved; the strategies, plans and objectives of Innoviva
(including Innoviva’s growth strategy and corporate development
initiatives beyond the existing respiratory portfolio); the timing,
manner, and amount of potential capital returns to shareholders;
the status and timing of clinical studies, data analysis and
communication of results; the potential benefits and mechanisms of
action of product candidates; expectations for product candidates
through development and commercialization; the timing of regulatory
approval of product candidates; and projections of revenue,
expenses and other financial items; the impact of the novel
coronavirus (COVID-19). Other risks affecting Innoviva are
described under the headings “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” contained in Innoviva’s Annual Report on Form 10-K for
the year ended December 31, 2022 and Quarterly Reports on Form
10-Q, which are on file with the Securities and Exchange Commission
(SEC) and available on the SEC’s website at www.sec.gov. Past
performance is not necessarily indicative of future 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. The information in this press release
is provided only as of the date hereof, and Innoviva assumes no
obligation to update its forward-looking statements on account of
new information, future events or otherwise, except as required by
law.
References _______________________ 1 Spellberg B,
Rex JH. The Value of Single-Pathogen Antibacterial Agents. National
Review Drug Discovery. 2013 Dec;12(12):963. doi:
10.1038/nrd3957-c1. Epub 2013 Nov 15. 2 Gupta V, Ye G, Olesky M,
Lawrence K, Murray J, Yu K. National Prevalence Estimates For
Resistant Enterobacteriaceae and Acinetobacter Species In
Hospitalized Patients In the United States. International Journal
of Infectious Disease. 2019 Aug;85:203-211. doi:
10.1016/j.ijid.2019.06.017. Epub 2019 Jun 20. PMID: 31229615. 3
Kaye, Keith S.,Shorr, Andrew F., et al. Efficacy and Safety Of
Sulbactam–Durlobactam Versus Colistin for the Treatment Of Patients
With Serious Infections Caused By Acinetobacter
baumannii–calcoaceticus Complex: a Multicentre, Randomised,
Active-Controlled, Phase 3, Non-Inferiority Clinical Trial
(ATTACK). The Lancet: Infectious Disease. Published May 11, 2023.
DOI: https://doi.org/10.1016/S1473-3099(23)00184-6. 4 Katip W,
Uitrakul S, Oberdorfer P. Clinical Efficacy and Nephrotoxicity of
the Loading Dose Colistin for the Treatment of Carbapenem-Resistant
Acinetobacter baumannii in Critically Ill Patients. Pharmaceutics.
2021 Dec 24;14(1):31. doi: 10.3390/pharmaceutics14010031. PMID:
35056926; PMCID: PMC8780224. 5 Ballouz T, Aridi J, Afif C, et al.
(2017) Risk Factors, Clinical Presentation, and Outcome of
Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol.
7:156. doi: 10.3389/fcimb.2017.00156 6 Kyriakidis I, Vasileiou E,
Pana ZD, Tragiannidis A. Acinetobacter baumannii Antibiotic
Resistance Mechanisms. Pathogens. 2021 Mar 19;10(3):373. doi:
10.3390/pathogens10030373. PMID: 33808905; PMCID: PMC8003822. 7
Centers for Disease Control and Prevention, “Carbapenem-Resistant
Acinetobacter baumannii (CRAB): An Urgent Public Health Threat in
United States healthcare facilities,” August 2021:
https://arpsp.cdc.gov/story/cra-urgent-public-health-threat.
Accessed: September 8, 2023 8 Antimicrobial Resistance
Collaborators. Global Burden Of Bacterial Antimicrobial Resistance
in 2019: a Systematic Analysis. Lancet. 2022; 399(10325):629-655.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
9 World Health Organization, “WHO Publishes List Of Bacteria For
Which New Antibiotics Are Urgently Needed,” February 27, 2017:
https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed.
Accessed: September 8, 2023
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Investors Argot Partners (212) 600-1902
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