Basilea announces that FDA approves expanded use of antifungal
Cresemba® (isavuconazole) in the United States in children with
invasive aspergillosis and invasive mucormycosis
Allschwil, Switzerland, December 11, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a
commercial-stage biopharmaceutical company committed to meeting the
needs of patients with severe bacterial and fungal infections,
announced today that its license partner Astellas Pharma US, Inc.
(“Astellas”) received the approval of Cresemba® (isavuconazole) for
the treatment of invasive aspergillosis (IA) and invasive
mucormycosis (IM) in pediatric patients by the US Food and Drug
Administration (FDA). Cresemba for injection is approved for adults
and now for pediatric patients 1 year of age and older. Cresemba
capsules are approved for adults and now for pediatric patients 6
years of age and older, who weigh 16 kilograms and greater.
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We
congratulate Astellas on the approval of Cresemba for the use in
children who suffer from invasive aspergillosis or mucormycosis.
These severe mold infections primarily affect children suffering
from hematologic malignancies, or other immunodeficiency disorders
and there is a high unmet medical need for new antifungal treatment
options in the pediatric population. We are pleased that access to
Cresemba is now available to this vulnerable patient
population.”
The approval is based on results from two pediatric clinical
studies, including a phase 2 open label, non-comparative,
multicenter study evaluating the safety, efficacy and
pharmacokinetics of Cresemba for the treatment of IA and IM in
pediatric patients aged 1 to 17 years old.1, 2
In addition, the FDA granted pediatric exclusivity for Cresemba,
which extends the period of market exclusivity for Cresemba in the
United States by an additional six months to September 2027.
In Europe, Basilea submitted a similar application for a
pediatric label extension of Cresemba in August 2023. This
application is currently under assessment by the European Medicines
Agency (EMA). Basilea anticipates a decision by the European
Commission in the first half of 2024. Upon completion of this
regulatory procedure, Cresemba would be eligible to an additional
two years of market exclusivity in the European Union, until
October 2027.
Cresemba is approved in 76 countries to date and is currently
marketed in 71 countries, including the United States, most EU
member states and additional countries inside and outside of
Europe. According to the latest available market data, total global
in-market sales of Cresemba in the twelve months between July 2022
and June 2023 amounted to USD 421 million, a 19 percent growth
year-on-year.3
About Cresemba®
(isavuconazole as isavuconazonium sulfate)
Isavuconazole, is an intravenous (i.v.) and oral azole
antifungal, commercialized under the trade name Cresemba®. Basilea
has entered into several license and distribution agreements for
isavuconazole covering approximately 115 countries. In the
27 European Union member states, as well as in Iceland,
Liechtenstein, Norway and the U.K., isavuconazole is approved for
the treatment of adult patients with invasive aspergillosis and for
adult patients with mucormycosis for whom amphotericin B is
inappropriate.4 Isavuconazole is also approved in several
additional countries in Europe and beyond, including Japan and
China.5 It has orphan drug designation in the US, Europe and
Australia for its approved indications.
In the United States, Cresemba is indicated for the treatment of
invasive aspergillosis and invasive mucormycosis as follows:
- Cresemba for injection: adults and
pediatric patients 1 year of age and older
- Cresemba capsules: adults and
pediatric patients 6 years of age and older, who weigh
16 kilograms and greater
Specimens for fungal culture and other relevant laboratory
studies (including histopathology) to isolate and identify
causative organism(s) should be obtained prior to initiating
antifungal therapy. Therapy may be instituted before the results of
the cultures and other laboratory studies are known. However, once
these results become available, antifungal therapy should be
adjusted accordingly.
Important US Safety Information for Cresemba
(isavuconazonium sulfate)
Contraindications
- Cresemba is contraindicated in
persons with known hypersensitivity to isavuconazole
- Coadministration of strong CYP3A4
inhibitors, such as ketoconazole or high-dose ritonavir (400 mg
every 12 hours), with Cresemba is contraindicated because strong
CYP3A4 inhibitors can significantly increase the plasma
concentration of isavuconazole
- Coadministration of strong CYP3A4
inducers, such as rifampin, carbamazepine, St. John's wort, or long
acting barbiturates with Cresemba is contraindicated because strong
CYP3A4 inducers can significantly decrease the plasma concentration
of isavuconazole
- Cresemba shortened the QTc interval
in a concentration-related manner. Cresemba is contraindicated in
patients with familial short QT syndrome
Warnings and Precautions
Hepatic Adverse Drug Reactions (e.g., elevations in ALT, AST,
alkaline phosphatase, total bilirubin) have been reported in
clinical trials and were generally reversible and did not require
discontinuation of Cresemba. Cases of severe hepatic adverse drug
reactions including hepatitis, cholestasis or hepatic failure,
including death, have been reported in patients with serious
underlying medical conditions (e.g., hematologic malignancy) during
treatment with azole antifungal agents, including Cresemba.
Evaluate liver tests at the start and during therapy. Monitor
patients who develop liver abnormalities during Cresemba therapy
for severe hepatic injury. Discontinue if clinical signs and
symptoms consistent with liver disease develop that may be
attributable to Cresemba.
Infusion-Related Reactions including hypotension, dyspnea,
chills, dizziness, paresthesia, and hypoesthesia were reported
during intravenous administration of Cresemba. Discontinue the
infusion if these reactions occur.
Hypersensitivity Reactions: Anaphylactic reactions, with fatal
outcome, have been reported during treatment with Cresemba. Serious
skin reactions, such as Stevens Johnson syndrome, have been
reported during treatment with other azole antifungal agents.
Discontinue Cresemba if anaphylactic or serious skin reactions
occur, and initiate supportive treatment as needed.
Embryo-Fetal Toxicity: During pregnancy, Cresemba may cause
fetal harm when administered, and Cresemba should only be used if
the potential benefit to the patient outweighs the risk to the
fetus. Women who become pregnant while receiving Cresemba are
encouraged to contact their physician.
Drug Interactions: Coadministration of Cresemba with strong
CYP3A4 inhibitors such as ketoconazole or high-dose ritonavir and
strong CYP3A4 inducers such as rifampin, carbamazepine, St. John's
Wort, or long acting barbiturates is contraindicated.
Drug Particulates: Following dilution, Cresemba intravenous
formulation may form precipitate from the insoluble isavuconazole.
Administer Cresemba through an in-line filter.
Adverse Reactions
In adult patients, the most frequently reported adverse
reactions among Cresemba-treated patients were nausea (26%),
vomiting (25%), diarrhea (22%), headache (17%), elevated liver
chemistry tests (16%), hypokalemia (14%), constipation (13%),
dyspnea (12%), cough (12%), peripheral edema (11%), and back pain
(10%).
In adult patients, the adverse reactions which most often led to
permanent discontinuation of Cresemba therapy during the clinical
trials were confusional state (0.7%), acute renal failure (0.7%),
increased blood bilirubin (0.5%), convulsion (0.5%), dyspnea
(0.5%), epilepsy (0.5%), respiratory failure (0.5%), and vomiting
(0.5%).
In pediatric patients, the most frequently reported adverse
reactions were diarrhea (26%), abdominal pain (23%), vomiting
(21%), elevated liver chemistry tests (18%), rash (14%), nausea
(13%), pruritus (13%), and headache (12%).
In general, adverse reactions in pediatric patients (including
serious adverse reactions and adverse reactions leading to
permanent discontinuation of Cresemba ) were similar to those
reported in adults.
For Full US Prescribing Information, please visit here:
https://www.astellas.us/docs/cresemba.pdf
About invasive aspergillosis and invasive
mucormycosis
Invasive aspergillosis (IA) and invasive mucormycosis (IM) are
life-threatening mold infections that predominantly affect
immunocompromised patients, including patients with hematologic
malignancies (blood cancer), transplant patients, or patients with
other immunodeficiency disorders. These infections are associated
with high morbidity and mortality, also in pediatric patients.6, 7,
8
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 and 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 and clinical 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, PhD Head 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 press release can be downloaded from www.basilea.com.
References
- ClinicalTrials.gov identifier: NCT03816176A. C. Arrieta,
H. Segers, J. D. Deville et al. Safety and Outcomes of
Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis
or Invasive Mucormycosis in Pediatric Patients. IDWeek 2023,
Abstract #1124
- ClinicalTrials.gov identifier: NCT03241550A. C. Arrieta,
M. Neely, J. C. Day, et al. Tolerability, and Population
Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in
Pediatric Patients. Antimicrobial Agents and Chemotherapy
2021;65(8):e0029021
- IQVIA Analytics Link, June 2023. In-market sales reported as
moving annual total (MAT) in US dollar.
- European Public Assessment Report (EPAR) Cresemba:
https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed:
December 10, 2023]
- The registration status and approved indications may vary from
country to country.
- J. Cadena, G. R. Thompson 3rd, T. F..Patterson.
Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious
Disease Clinics of North America 2021 (35), 415-434
- M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive
infections due to filamentous fungi other than Aspergillus:
epidemiology and determinants of mortality. Clinical Microbiology
and Infection 2015 (21), 490.e1-490.e10
- Z. D. Pana E. Roilides, A. Warris et al. Epidemiology of
Invasive Fungal Disease in Children. Journal of the Pediatric
Infectious Diseases Society 2017 (6), suppl. 1, S3-S11
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