Sanofi, DNDi seek EMA review for sleeping sickness treatment1 Feb 2018
Fexinidazole would be first all-oral treatment under investigation for both first and second stages of sleeping sickness, a fatal disease, endemic in Africa.
Sanofi has asked the EMA to review fexinidazole for the treatment of sleeping sickness. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi). It would be the first all-oral treatment under investigation for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT), commonly known as sleeping sickness. It is hoped that this treatment will contribute to the elimination of the disease.
EMA has accepted the application under a special procedure called "Article 58" which allows the EMA to give a scientific opinion, in co-operation with the World Health Organization (WHO), for the evaluation of medicinal products that are intended exclusively for markets outside of the European Union. Fexinidazole was previously granted accelerated assessment by the EMA.
"The acceptance by the EMA of the fexinidazole regulatory dossier is a critical step in the registration process," said Dr Nathalie Strub-Wourgaft, DNDi Medical Director. "Results of the Phase II/III clinical trials conducted with our partners in Democratic Republic of Congo and the Central African Republic showed the product to be effective and well tolerated."
Following the evaluation of the dossier, the EMA will publish its scientific opinion of the benefit risk of the treatment, which will facilitate the registration of fexinidazole in HAT-endemic countries.
"This milestone is the result of an innovative collaboration between Sanofi and DNDi to address the burden of sleeping sickness," said Dr Ameet Nathwani, Chief Medical Officer, Sanofi. "Fexinidazole is being developed with the goal of addressing all stages of sleeping sickness and simplifying treatment by avoiding systematic hospitalization. It could represent a therapeutic breakthrough foremost for the patients and potentially support elimination efforts as per the WHO 2020 Roadmap."
Oxford Genetics signs major supply and licensing agreement for CRISPR engineered mammalian cell lines
8 Aug 2018
Company moves away from manual processing in favour of automated, scalable platforms.Read more
A new era for migraine patients
6 Aug 2018
EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.Read more
WuXi STA and Antengene sign development and manufacturing agreement
24 Jul 2018
WuXi STA chosen for its end-to-end CMC platform for new drug development.Read more
ProBioGen and Pionyr initiate 2nd immuno-oncology contract development and manufacturing project
18 Jul 2018
Parallel cell line development and analysis will allow for optimal cell line selection while compressing the development timeline.Read more
New screening company exploits the latest advances in microfluidics and 3D culture
19 Jul 2018
The ability to micro size drug-cell interactions will allow pharmaceutical and biotech companies to do 100x more testing for the same money spent as well as increasing productivity.Read more
Natural lipid acts as potent anti-inflammatory
10 Jul 2018
Scientists see therapeutic potential against bacteria, viruses.Read more
Plasticell leads gene therapy manufacturing consortium
3 Jul 2018
Consortium to develop advanced technologies for the manufacturing of ex vivo gene therapies.Read more
Follicum develops new direct-to-scalp formulation
27 Jun 2018
The topical treatment for hair loss boasts a 'commercial' formulation.Read more
Collaboration to provide GMP-based services
19 Jun 2018
Researchers to benefit by receiving a rapid and cost-effective scaled supply of new compounds.Read more
Locate Therapeutics secures £2 million to fast-track development of innovative cell therapy programs
5 Jun 2018
TAOS matrix system and products hailed as potential ‘game changers’ in the field of regenerative medicine.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation