Human medicines European public assessment report (EPAR): Hyftor, sirolimus, Angiofibroma;Tuberous Sclerosis, Date of authorisation: 15/05/2023, Status: Authorised
Hyftor is a medicine used to treat benign (non-cancerous) skin tumours on the face (facial angiofibroma) that are caused by a genetic disease called tuberous sclerosis complex. It is used in adults and children aged 6 years and older.
Tuberous sclerosis complex is rare, and Hyftor was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 23 August 2017. Further information on the orphan designation can be found on the EMA website.
Hyftor is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Hyftor is given in a different way. While the reference medicine, Rapamune, is given by mouth (tablets or a liquid to be drunk), Hyftor is available as a gel to be applied to the skin.
Hyftor contains the active substance sirolimus.