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LONDON, Jan. 7, 2025
/PRNewswire/ -- Norgine today announced that it completed its
marketing authorisation application filing to European Medicines
Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB).
This follows the submissions in April
2024, via Project Orbis, in Australia, Switzerland and the United Kingdom.
This milestone further supports Norgine's efforts to give
patients 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 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
patients treated with eflornithine in Study 3b
(NCT02395666)[2],[4] to control patients
derived from Study ANBL0032 (NCT00026312; clinical-trial-derived
external control arm)[3],[4]. The study with
eflornithine treated patients showed improved event-free survival
and overall survival when compared to outcomes for patients with
HRNB treated with the standard of care
(SoC).[1]
Dr David Gillen, Chief
Medical Officer at Norgine, added, "This submission via the EU
Centralised Procedure represents another important step in the
regulatory process for eflornithine and further emphasises
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."
Janneke van der Kamp, CEO
of Norgine added "Submitting this marketing authorisation to the
EMA marks a pivotal step for patients facing this challenging
cancer. We are committed to advancing innovative therapies that
address the unmet needs of young patients and their families, and
this milestone brings us closer to offering hope where it's most
needed".
www.norgine.com
Follow @norgine
Notes to Editors:
HRNB background
Children diagnosed with HRNB undergo an intense SoC regimen that
still leaves them vulnerable to relapse and death, a risk that is
highest for the first two years after completing
treatment.[5] Approximately 30% of
patients who attain remission following upfront therapy will
relapse, and once relapsed, mortality significantly increases with
a post-relapse 4-year overall survival of under
10%.[5], [6] Therefore, 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 demonstrate that using eflornithine after completion of
upfront SoC treatment, as post-maintenance therapy extends
remission and reduces risk of relapse in patients with HRNB.
About Norgine
Norgine is a uniquely positioned, specialty pharmaceutical and
consumer healthcare company, with over €500 million of annual
revenues and a 120-year track record of bringing life-changing
products to patients and consumers across our core markets of
Western Europe, Australia and New
Zealand.
Our integrated approach – strong commercial capabilities, deep
medical, regulatory and clinical expertise, in-house manufacturing,
robust supply networks, and best in class enabling functions –
ensures that we can deliver high-quality, transformative medicines
quickly and effectively to over 25 million patients annually.
Today's Norgine is a nimble, innovative, and high-performing
company that has been transformed by a relentless focus on
operational excellence. This focus will enable us to secure the
legacy of more than a century of innovation and doing the right
thing by our patients, as we push the boundaries and take strides
into new therapeutic areas.
NORGINE and the sail logo are trademarks of the Norgine group of
companies.
References
- FDA approves eflornithine for adult and pediatric patients with
high-risk neuroblastoma. FDA. News release. 13 December 2023. Available from: FDA
approves eflornithine for adult and pediatric patients with
high-risk neuroblastoma | FDA
- Clinical Trial NCT02395666; Preventative trial of
difluoromethylornithine (DFMO) in high risk patients with
neuroblastoma that is in remission. Available from: Study
Details | Preventative Trial of Difluoromethylornithine (DFMO) in
High Risk Patients With Neuroblastoma That is in Remission |
ClinicalTrials.gov.
- Clinical Trial NCT00026312; Isotretinoin with or without
dinutuximab,[1] aldesleukin, and sargramostim following
stem cell transplant in treating patients with neuroblastoma.
Available from: Study Details | Isotretinoin With or Without
Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell
Transplant in Treating Patients With Neuroblastoma |
ClinicalTrials.gov
- 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.
- 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.
- 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.[2]
Job code: UK-ONC-NP-2400019
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