Takeda reports EMEA filing of SNT-MC17

Takeda Pharmaceutical and Santhera Pharmaceuticals have reported that their filing for SNT-MC17 (idebenone) as a treatment for Friedreich’s Ataxia (FRDA) has been accepted for review by the European Medicines Agency (EMEA).

Potentially the first approved treatment for FRDA, SNT-MC17 has exhibited efficacy on the cardiac and neurological endpoints of clinical studies in FRDA patients, while it has also been well-tolerated.

The companies report that – if approved – the compound will be marketed by Takeda in Europe.

Following this announcement, a milestone payment of three million euros (two million pounds) from Takeda to Santhera has been triggered.

Yasuchika Hasegawa, president of Takeda, said: “We are pleased with this important progress in development of SNT-MC17 for FRDA by Santhera while there is currently no effective pharmacological treatment for this disease.

He forecast that the company’s partnership working efforts with Santhera will deliver significant benefit to FRDA patients.

Klaus Schollmeier, chief executive officer of Santhera, attributed the success of the EMEA filing to the work of specialists and support from its partners, including Takeda.

Earlier this month, Takeda and Santhera announced an extension to their marketing agreement for SNT-MC17, with the deal now covering the additional indication of Duchenne muscular dystrophy.