Hyftor (sirolimus 2 mg/g gel) is launched in Europe to treat facial angiofibroma associated with tuberous sclerosis complex

Hyftor in topical gel formulation is the first treatment approved in the EU/EEA countries and the UK for facial angiofibroma associated with TSC. Approximately 51,000 and 4,700 people have TSC respectively in Europe and the UK, of whom estimated 40,800 and 3,700 have facial angiofibroma respectively.

Being the world's first topical formulation approved with the indication of skin lesions associated with TSC in Japan under the SAKIGAKE fast-track review system, this drug was launched under the name of “Rapalimus Gel 0.2%” in June 2018 with orphan drug designation. This is the second international product launched following the United States (launched on August 29, 2022), which will be provided to patients in Germany and other EU/EEA countries as well as the UK through its European subsidiary, Plusultra pharma GmbH