Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole
2023年10月2日 - 2:15PM
Basilea announces FDA acceptance of New Drug Application for
antibiotic ceftobiprole
- Seeking approval
for Staphylococcus aureus
bacteremia (SAB), acute bacterial skin and skin structure
infections (ABSSSI), and community-acquired bacterial pneumonia
(CABP)
- Prescription Drug User Fee
Act (PDUFA) goal date set for April 03, 2024
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, October 02, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a
commercial-stage biopharmaceutical company committed to meeting the
needs of patients with severe bacterial or fungal infections,
announced today that the US Food and Drug Administration (FDA) has
accepted for filing the New Drug Application (NDA) for the
antibiotic ceftobiprole, which was submitted to the FDA on August
3rd this year. With this NDA, Basilea is seeking approval for
treating patients in three indications: Staphylococcus aureus
bacteremia (SAB), including right-sided infective endocarditis,
acute bacterial skin and skin structure infections (ABSSSI) and
community-acquired bacterial pneumonia (CABP). The FDA has set
April 03, 2024, as the Prescription Drug User Fee Act (PDUFA) goal
date.
The PDUFA goal date indicates the date for the FDA to complete
its review of the NDA, which is supported by clinical efficacy and
safety data from the phase 3 studies ERADICATE (SAB),1 TARGET
(ABSSSI),2 and a phase 3 study in CABP.3 The ERADICATE study was
the largest double-blind randomized registrational study conducted
for a new antibiotic treatment in SAB.
Dr. Marc Engelhardt, Chief Medical Officer, said: “We are
pleased with the FDA's acceptance of our New Drug Application,
which is another important step towards bringing ceftobiprole to
patients with severe bacterial infections in the US, as there is a
high medical need for new antibiotic treatment options, especially
in complicated SAB. We look forward to working closely with the FDA
throughout their review process.”
Ceftobiprole has been designated a Qualified Infectious Disease
Product (QIDP) under the US Generate Antibiotics Incentives Now
(GAIN) Act; hence, subject to approval, ceftobiprole would be
eligible to receive ten years of market exclusivity in the US from
the date of approval. Basilea is planning to commercialize
ceftobiprole in the US through a partner and intends to enter into
such a partnership prior to the PDUFA goal date.
Basilea’s ceftobiprole phase 3 program is funded in part with
federal funds from the US Department of Health and Human Services
(HHS); Administration for Strategic Preparedness and Response
(ASPR); Biomedical Advanced Research and Development Authority
(BARDA), under contract number HHSO100201600002C. Basilea has been
awarded approximately USD 112 million, or approximately
75 percent of the costs related to the SAB and ABSSSI phase 3
studies, regulatory activities and non-clinical work.
About ceftobiprole
Ceftobiprole, the active moiety of the prodrug ceftobiprole
medocaril, is an advanced generation cephalosporin antibiotic for
intravenous administration, with rapid bactericidal activity
against a wide range of Gram-positive bacteria such as
Staphylococcus aureus, including methicillin-resistant strains
(MRSA), and Gram-negative bacteria.4 The brand is currently
approved and marketed as Zevtera® and Mabelio® in several countries
in Europe and beyond, for the treatment of adult patients with
hospital-acquired bacterial pneumonia (HABP), excluding
ventilator-associated bacterial pneumonia (VABP), and for the
treatment of community-acquired bacterial pneumonia (CABP). Basilea
has entered into license and distribution agreements covering more
than 80 countries. Ceftobiprole is currently not approved or
partnered in the US.
About Basilea
Basilea is a commercial-stage biopharmaceutical company founded
in 2000 and headquartered in Switzerland. We are committed to
discovering, developing and commercializing innovative drugs to
meet the needs of patients with severe bacterial or fungal
infections. We have successfully launched two hospital brands,
Cresemba for the treatment of invasive fungal infections and
Zevtera for the treatment of bacterial infections. In addition, we
have preclinical anti-infective assets in our portfolio. Basilea is
listed on the SIX Swiss Exchange (SIX: BSLN). Please visit
basilea.com.
Disclaimer
This communication expressly or implicitly contains certain
forward-looking statements, such as "believe", "assume", "expect",
"forecast", "project", "may", "could", "might", "will" or similar
expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its
business, including with respect to the progress, timing and
completion of research, development and clinical studies for
product candidates. Such statements involve certain known and
unknown risks, uncertainties and other factors, which could cause
the actual results, financial condition, performance or
achievements of Basilea Pharmaceutica Ltd, Allschwil to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements. Basilea Pharmaceutica Ltd, Allschwil is providing this
communication as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new
information, future events or otherwise.
For further information, please contact:
Peer Nils Schröder, PhDHead of Corporate
Communications & Investor RelationsBasilea Pharmaceutica Ltd,
Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland |
Phone |
+41 61 606 1102 |
E-mail |
media_relations@basilea.cominvestor_relations@basilea.com |
This ad hoc announcement can be downloaded from
www.basilea.com.
References
- ERADICATE: ClinicalTrials.gov identifier
NCT03138733T. L. Holland, S. E. Cosgrove,
S. B. Doernberg et al. Ceftobiprole for treatment of
complicated Staphylococcus aureus bacteremia. New England Journal
of Medicine 2023 Sep 27; DOI: 10.1056/NEJMoa2300220. Epub ahead of
print.
- TARGET: ClinicalTrials.gov identifier
NCT03137173J. S. Overcash, C. Kim, R. Keech R
et al. Ceftobiprole compared with vancomycin plus aztreonam in the
treatment of acute bacterial skin and skin structure infections:
Results of a phase 3, randomized, double-blind trial (TARGET).
Clinical Infectious Diseases 2021 (73), e1507-e1517
- CABP study: ClinicalTrials.gov identifier NCT00326287S. C.
Nicholson, T. Welte, T. M. File Jr. et al. A randomised,
double-blind trial comparing ceftobiprole medocaril with
ceftriaxone with or without linezolid for the treatment of patients
with community-acquired pneumonia requiring hospitalization.
International Journal of Antimicrobial Agents 2012 (39),
240-246
- Summary of Product Characteristics (SmPC) Zevtera:
https://www.medicines.org.uk/emc/product/9164/smpc [Accessed
October 01, 2023]
Basilea Pharmaceutica (LSE:0QNA)
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Basilea Pharmaceutica (LSE:0QNA)
過去 株価チャート
から 6 2023 まで 6 2024