DIFICID® Pediatric Filings Receive Priority
Review Classification
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the U.S. Food and Drug Administration (FDA)
has accepted for review a New Drug Application (NDA) for DIFICID®
(fidaxomicin) for oral suspension, and a supplemental NDA (sNDA)
for a new indication for use of DIFICID tablets and oral suspension
for the treatment of Clostridium (also known as Clostridioides)
difficile infections (CDI) in children aged six months or older.
Both applications have received a priority review classification by
the FDA. The Prescription Drug User Fee Act (PDUFA), or target
action date for both applications, is set for Jan. 24, 2020. The
investigational pediatric indication for DIFICID was granted Orphan
Drug Designation (ODD) in 2010.
“Evidence indicates the increasing incidence of C.
difficile-associated diarrhea among hospitalized children1,” said
Dr. Nicholas Kartsonis, senior vice president, Clinical Research,
infectious diseases and vaccines, Merck Research Laboratories. “The
filings for the pediatric indication for the new investigational
oral suspension formulation of DIFICID, as well as for DIFICID
tablets, underscore Merck’s focus and dedication to developing
infectious disease treatments for those with unmet needs.”
The sNDA is based primarily on results of the Phase 3 SUNSHINE
study2, which were presented as part of the Late Breaker Oral
Abstracts on Emerging Infections at IDWeek 2018 in San Francisco,
California.
About DIFICID (fidaxomicin)
DIFICID is a macrolide antibacterial medicine indicated in
adults (18 years of age or older) for treatment of Clostridium
difficile-associated diarrhea (CDAD). To reduce the development of
drug-resistant bacteria and maintain the effectiveness of DIFICID
and other antibacterial drugs, DIFICID should be used only to treat
infections that are proven or strongly suspected to be caused by
Clostridium difficile. DIFICID is contraindicated in patients who
have known hypersensitivity to fidaxomicin or any other ingredient
in DIFICID. DIFICID should only be used for the treatment of C.
difficile-associated diarrhea. DIFICID is not effective for
treatment of other types of infections due to minimal systemic
absorption of fidaxomicin.
About Clostridium difficile
Clostridium difficile, also known as C. difficile or C. diff, is
one of the most common causes of health care-associated infections
in U.S. hospitals.3 Recent estimates suggest C. difficile causes
almost 500,000 infections annually in the United States and is
associated with approximately 29,000 deaths within 30 days of
initial diagnosis.4
Important Safety Information about DIFICID
(fidaxomicin)
DIFICID is contraindicated in patients who have known
hypersensitivity to fidaxomicin or any other ingredient in
DIFICID.
DIFICID should only be used for the treatment of C.
difficile-associated diarrhea. DIFICID is not effective for
treatment of other types of infections due to minimal systemic
absorption of fidaxomicin .
Acute hypersensitivity reactions, including dyspnea, rash
pruritus, and angioedema of the mouth, throat, and face have been
reported with DIFICID. If a severe hypersensitivity reaction
occurs, DIFICID should be discontinued and appropriate therapy
should be instituted.
Only use DIFICID for infection proven or strongly suspected to
be caused by C. difficile. Prescribing DIFICID in the absence of a
proven or strongly suspected C. difficile infection is unlikely to
provide benefit to the patient and increases the risk of
development of drug-resistant bacteria.
The most common adverse reactions reported in clinical trials
are nausea (11%), vomiting (7%), abdominal pain (6%),
gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia
(2%).
Among patients receiving DIFICID (fidaxomicin), 33 (5.9%)
withdrew from trials as a result of adverse reactions. Vomiting was
the primary adverse reaction leading to discontinuation of dosing
(incidence of 0.5% for both DIFICID and vancomycin patients).
The safety and effectiveness of DIFICID in patients less than18
years of age have not been established.
The recommended dose of DIFICID is one 200 mg tablet orally
twice daily for 10 days, with or without food.
No dose adjustment is recommended for patients 65 years of age
or older.
No dose adjustment is recommended for patients with renal
impairment.
No dosage adjustments are recommended when co-administering
DIFICID with substrates of P-gp or CYP enzymes.
The impact of hepatic impairment on the pharmacokinetics of
DIFICID has not been evaluated; however, because DIFICID and its
active metabolite (OP-1118) do not appear to undergo significant
hepatic metabolism, elimination of DIFICID and OP-1118 is not
expected to be significantly affected by hepatic impairment.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
antibiotic, antiviral and antifungal medicines, vaccines, and
medicines for HIV and HCV, Merck has multiple programs that span
discovery through late-stage development. To learn more about
Merck’s infectious diseases pipeline, visit www.merck.com.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2018
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see U.S. Prescribing Information for DIFICID
(fidaxomicin) at
https://www.merck.com/product/usa/pi_circulars/d/dificid/dificid_pi.pdf,
and Patient Information for DIFICID (fidaxomicin) at
https://www.merck.com/product/usa/pi_circulars/d/dificid/dificid_ppi.pdf.
1 Pant, Chaitanya. “Rising Incidence of Clostridium Difficile
Related Discharges among Hospitalized Children in the United
States.” Infection Control & Hospital Epidemiology, vol. 37,
Jan. 2016, pp. 104–106.
2 The SUNSHINE Study was sponsored by Astellas Pharma Europe BV,
Inc. and partially supported by Merck.
3 Lessa, Fernanda. “Burden of Clostridium difficile Infection in
the United States.” The New England Journal of Medicine, vol. 372,
Feb. 2015, pp.825-834.
4 Ibid.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191002005132/en/
Media: Pam Eisele (267) 305-3558
Sarra Herzog (201) 669-6570
Investors: Peter Dannenbaum (908) 740-1037
Michael DeCarbo (908) 740-1807
Merck (NYSE:MRK)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024
Merck (NYSE:MRK)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024