Eflornithine
- Generic Name
- Eflornithine
- Brand Names
- Vaniqa
- Drug Type
- Small Molecule
- Chemical Formula
- C6H12F2N2O2
- CAS Number
- 70052-12-9
- Unique Ingredient Identifier
- ZQN1G5V6SR
- Background
Eflornithine is a prescription drug indicated in the treatment of facial hirsutism (excessive hair growth). Eflornithine hydrochloride cream for topical application is intended for use in women suffering from facial hirsutism and is sold by Allergan, Inc. under the brand name Vaniqa. Eflornithine for injection against sleeping sickness was manufactured by Sanofi Aventis and sold under the brand name Ornidyl in the USA. It is now discontinued. Eflornithine is on the World Health Organization's List of Essential Medicines.
- Indication
Eflornithine is indicated in the treatment of facial hirsutism (excessive hair growth).
- Associated Conditions
- Meningoencephalitic stage Trypanosoma brucei gambiense infection
- Associated Therapies
- Hair removal therapy
Pharmacist’s Application to Practice: Eflornithine for High-Risk Neuroblastoma
FDA approved eflornithine for reducing relapse risk in high-risk neuroblastoma patients post-therapy. It inhibits polyamine synthesis, improving survival rates. Common side effects include otitis media and sinusitis. NCCN recommends it post anti-GD2 therapy. Eflornithine presents a promising treatment avenue for high-risk neuroblastoma.
Iwilfin (eflornithine) approved by the FDA as the first and only maintenance therapy for high-risk neuroblastoma
Neuroblastoma, a pediatric cancer from neural crest cells, involves complex genetic changes like MYCN amplification. High-risk neuroblastoma (HRNB) treatments include immunotherapy, chemotherapy, and surgery, with dinutuximab beta being effective but having side effects. New treatments like DFMO show promise in improving survival rates, though side effects remain a concern. Research focuses on minimizing toxicity and personalizing treatment approaches.
Norgine B.V. submits Marketing Authorisation Application via Project Orbis for Eflornithine in High-Risk Neuroblastoma
Norgine B.V. submitted its first marketing authorisation applications for eflornithine in high-risk neuroblastoma (HRNB) via Project Orbis in Australia, Switzerland, and the UK on 10 April 2024. Eflornithine, approved by the FDA on 13 December 2023, is the first oral maintenance therapy for HRNB, showing improved survival rates. Norgine aims to expand treatment options for HRNB patients, emphasizing the drug's potential to reduce relapse risk.
Norgine B.V.通过Project Orbis提交高风险神经母细胞瘤中依氟甲基鸟氨酸的上市许可申请
Norgine B.V. submitted its first marketing authorisation application for eflornithine in high-risk neuroblastoma (HRNB) via Project Orbis in Australia, Switzerland, and the UK. This follows FDA's approval of eflornithine as the first oral maintenance therapy for HRNB, showing improved survival rates. Norgine's efforts aim to provide additional treatment options for HRNB patients, highlighting the drug's potential to reduce relapse risk.
Norgine B.V. submits Marketing Authorisation Application for eflornithine in high-risk neuroblastoma
Norgine B.V. submitted marketing authorisation applications for eflornithine in high-risk neuroblastoma via Project Orbis in Australia, Switzerland, and the UK. Eflornithine, approved by the FDA for reducing relapse risk in HRNB, shows improved survival rates. Norgine aims to expand treatment options for HRNB patients globally.
Eflornithine Is Approved by the FDA for High-Risk Neuroblastoma
FDA approved eflornithine (Vaniqa) for high-risk neuroblastoma patients showing partial response to prior treatment. Study 3b, involving 105 patients, compared eflornithine's efficacy and safety against an external control, showing improved survival rates. Common side effects included diarrhea, infections, and laboratory abnormalities.
FDA’S ODAC Votes Yes to Eflornithine for Pediatric Neuroblastomas
FDA’s Oncologic Drug Advisory Committee voted 14-6, supporting eflornithine (DFMO) for reducing relapse risk in pediatric high-risk neuroblastoma patients in remission. The decision, based on Study 3b with external control data from ANBL0032, marks a potential precedent. DFMO, targeting ornithine decarboxylase, showed 85% event-free survival vs. 70% in controls, with manageable risks.
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