- New Drug Application (NDA) for sulbactam-durlobactam 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), is currently under Priority Review by the FDA with
a PDUFA target action date of May 29, 2023
Innoviva, Inc. (Nasdaq: INVA) (Innoviva), a diversified holding
company with a portfolio of royalties and other healthcare assets,
today announced that the U.S. Food and Drug Administration’s (FDA)
Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted
12-0 in support of approval based on a favorable benefit-risk
assessment of sulbactam-durlobactam 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). The sulbactam-durlobactam New Drug Application
(NDA), filed by Entasis Therapeutics Inc., a wholly owned
subsidiary of Innoviva, was accepted and granted Priority Review by
the FDA in November 2022, with a Prescription Drug User Fee Act
(PDUFA) target action date of May 29, 2023.
“The Committee’s unanimous recommendation in favor of
sulbactam-durlobactam, the first pathogen-targeted therapy for
Acinetobacter, moves us closer to potentially addressing the urgent
need for new treatment options for patients with serious and
life-threatening infections caused by this pathogen,” said David
Altarac, MD, Chief Medical Officer, Entasis Therapeutics, a wholly
owned subsidary of Innoviva. “We appreciate the Committee’s
thoughtful deliberation and strong vote of confidence, and look
forward to working with the FDA as it completes its review.”
The Committee based its recommendation on the totality of
scientific evidence, including results from the landmark Phase 3
trial evaluating the safety and efficacy of sulbactam-durlobactam
versus colistin in patients with infections caused by
Acinetobacter. In the trial, sulbactam-durlobactam 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. Sulbactam-durlobactam also
exhibited a favorable safety profile with a statistically
significant lower incidence of nephrotoxicity as measured by
modified Risk–Injury–Failure–Loss and End-stage kidney disease
(RIFLE) criteria. The FDA will take the Committee’s recommendation
into consideration when it makes a final determination.
Infections caused by drug-resistant Acinetobacter are serious
and life-threatening conditions associated with high morbidity and
mortality1 and long, expensive hospital stays. 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.
The Centers for Disease Control and Prevention (CDC) has
identified carbapenem-resistant micro-organisms as an urgent
threat2. Globally, Acinetobacter baumannii was among the top six
leading pathogens for deaths associated with resistance in 20193.
Carbpenem-resistant Acinetobacter is considered a Priority 1
pathogen by the World Health Organization (WHO)4.
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. They can also
infect other body sites, such as the urinary tract and the skin.
Acinetobacter is considered a global threat in the healthcare
setting due in part to its ability to acquire multidrug resistance.
Based on current carbapenem resistance rates, we estimate there are
more than 300,000 hospital-treated carbapenem-resistant
Acinetobacter infections each year globally5 for which significant
morbidity and mortality exists due to limited treatment
options.
About sulbactam-durlobactam
Sulbactam-durlobactam is an intravenous, or IV, investigational
drug that is a combination of sulbactam, a beta-lactam
antibacterial, and durlobactam, a beta-lactamase inhibitor, being
developed for the treatment of hospital-acquired bacterial
pneumonia and ventilator-associated bacterial pneumonia caused by
susceptible strains of Acinetobacter baumannii-calcoaceticus
complex (Acinetobacter). Sulbactam-durlobactam has been designated
a Qualified Infectious Disease Product by the FDA, a designation
that aims to spur development of new antibiotics for serious and
life-threatening infections. In November 2022, the FDA accepted the
New Drug Application (NDA) for sulbactam-durlobactam for Priority
Review and set a Prescription Drug User Fee Act (PDUFA) target date
of May 29, 2023.
About Innoviva
Innoviva is a diversified holding company with a portfolio of
royalties and other healthcare assets. 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®. Innoviva’s other healthcare assets include infectious
disease and critical-care assets stemming from acquisitions of
Entasis Therapeutics Inc., including its lead asset
sulbactam-durlobactam, and La Jolla Pharmaceutical Company,
including 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.
ANORO®, RELVAR® and BREO® are trademarks of the GSK group of
companies.
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.
______________
1 Tala, B., Jad, A., Claude, A., Jihad, I., Chantal, L., Rakan,
N.,& Eid, A. (2017). Risk Factors, Clinical Presentation, and
Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect.
Microbiol., 04 May 2017, Sec. Molecular Bacterial Pathogenesis
Volume 7 – 2017: https://doi.org/10.3389/fcimb.2017.00156 2 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 3
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
4 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
5 Antimicrobial Resistance Collaborators. Global burden of
bacterial antimicrobial resistance in 2019: a systematic analysis.
Lancet. 2022; 399(10325):629-655. Supplementary Material.
Supplementary appendix.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
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Investors Argot Partners (212) 600-1902
innoviva@argotpartners.com Media Green Room Communications
(412) 327-9499 ISTMedia@grcomms.com
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