15.04.2024,
6953 Zeichen
Amsterdam (ots/PRNewswire) - Norgine B.V. today announced its first
marketing authorisation application submissions on 10 April 2024,
seeking approval for eflornithine in high-risk neuroblastoma (HRNB),
via Project Orbis in Australia, Switzerland and the United Kingdom.
This milestone supports Norgine's efforts to deliver patient access
to eflornithine and bring a further treatment option in the field of
paediatric oncology.
Norgine and USWM, LLC (dba US WorldMeds), a Kentucky-based specialty
pharmaceutical company, have an exclusive licensing agreement by
which Norgine will register and commercialise eflornithine, also
referred to as DFMO, in Europe, Australia and New Zealand.
On 13 December 2023, the US Food and Drug Administration (FDA)
approved eflornithine as the first oral maintenance therapy for
high-risk neuroblastoma (HRNB), indicated to reduce the risk of
relapse in adult and paediatric patients who have received certain
prior therapies.1 The approval decision was based on findings from a
trial comparing outcomes from Study 3b (NCT02395666; investigational
arm)2,4 and Study ANBL0032 (NCT00026312; clinical-trial-derived
external control arm)3,4, where use of eflornithine resulted in
improved event-free survival and overall survival when compared to
outcomes for patients with high-risk neuroblastoma treated with the
standard of care (SoC) without the drug.1
Dr David Gillen, Chief Medical Officer at Norgine, added, "These
submissions via Project Orbis represent an important first step in
the regulatory process for eflornithine and re-emphasise Norgine's
passion and commitment in attempting to secure additional treatment
options for patients living with HRNB, a condition with a high level
of unmet medical need."
www.norgine.com Follow @norgine
Notes to Editors:
Project Orbis
Project Orbis is an initiative (since May 2019) of the US FDA
Oncology Center of Excellence (OCE) and provides a framework for
concurrent submission and collaborative review of innovative oncology
products among international regulatory authorities. It was created
with the overarching goal to speed worldwide patient access to
innovative cancer therapies. Project Orbis is coordinated by the FDA,
and its partners include United Kingdom Medicines and Healthcare
Products regulatory Agency (UK MHRA), Australia Therapeutic Goods
Administration (TGA), Canada (Health Canada), Singapore (Health
Sciences Authority (HSA), Switzerland (Swissmedic), Brazil (Agência
Nacional de Vigilância Sanitária (ANVISA), Israel (Ministry of
Health).
HRNB background
Children diagnosed with HRNB undergo an intense SoC regimen that
still leaves them vulnerable to relapse and death, a risk that is
particularly acute during the first two years.5 Approximately 30% of
patients who attain remission following upfront therapy will relapse,
resulting in a poor prognosis and low likelihood of long-term
survival (e.g. estimates as low as 15% of patients will live for five
years after relapsing).6 Avoiding relapse is key to long-term
survival, yet outside of the United States there are no approved
therapies for sustaining remission following SoC treatment. The data
with eflornithine demonstrate using it as maintenance therapy extends
remission and reduces risk of relapse in patients with HRNB.
About Norgine
Norgine is a leading European specialist pharmaceutical company that
has been bringing transformative medicines to patients for over a
century. Our commitment to transforming people's lives drives
everything we do, and our European experience, fully integrated
infrastructure and exceptional partnership approach enable us to
quickly apply creative solutions to bring life-changing medicines to
patients that they may not otherwise be able to access. Norgine is
proud to have helped more than 25 million patients around the world
in 2022 and generated €530 million in net product sales, a growth of
nearly 5% over 2021.
Norgine has a direct presence in 16 European countries, as well as
Australia and New Zealand. We also have a strong global network of
partnerships in non-Norgine markets. We are a flexible and fully
integrated pharmaceutical business, with manufacturing (Hengoed,
Wales and Dreux, France), third party supply networks and significant
product development capabilities, in addition to our sales and
marketing infrastructure. This enables us to acquire, develop and
commercialise specialist and innovative products that make a real
difference to the lives of patients around the world.
NORGINE and the sail logo are trademarks of the Norgine group of
companies.
References
1. FDA approves eflornithine for adult and pediatric patients with
high-risk neuroblastoma. FDA. News release. 13 December 2023.
Available from: [1] FDA approves eflornithine for adult and
pediatric patients with high-risk neuroblastoma | FDA
2. Clinical Trial NCT02395666; Preventative trial of
difluoromethylornithine (DFMO) in high risk patients with
neuroblastoma that is in remission. Available from: [2] Study
Details | Preventative Trial of Difluoromethylornithine (DFMO) in
High Risk Patients With Neuroblastoma That is in Remission |
ClinicalTrials.gov .
3. Clinical Trial NCT00026312; Isotretinoin with or without
dinutuximab, aldesleukin, and sargramostim following stem cell
transplant in treating patients with neuroblastoma. Available
from: [3] Study Details | Isotretinoin With or Without
Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell
Transplant in Treating Patients With Neuroblastoma |
ClinicalTrials.gov
4. Oesterheld J, Ferguson W, Kraveka JM, Bergendahl G, Clinch T,
Lorenzi E et al. Eflornithine as Postimmunotherapy Maintenance in
High-Risk Neuroblastoma: Externally Controlled, Propensity
Score-Matched Survival Outcome Comparisons. 2024; 42 (1): 90-102.
5. Basta NO, Halliday GC, Makin G, Birch J, Feltbower R, Bown N, et
al. Factors associated with recurrence and survival length
following relapse in patients with neuroblastoma. Br J Cancer.
2016;115:1048-57.
6. London WB, Bagatell R, Weigel BJ, Fox E, Guo D, Van Ryn C, et
al.
Historical time to disease progression and progression-free
survival in patients with recurrent/refractory neuroblastoma
treated in the modern era on Children's Oncology Group
early-phase
trials. Cancer. 2017;123:4914-23.
1.
https://www.fda.gov/drugs/resources-information-ap...
proves-eflornithine-adult-and-pediatric-patients-high-risk-neuroblast
oma?utm_medium=email&utm_source=govdelivery
2.
https://clinicaltrials.gov/study/NCT02395666?term=NCT0239...
3.
https://clinicaltrials.gov/study/NCT00026312?term=NCT0002...
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