CHMP positive for Hyftor or the treatment of facial angiofibroma associated with tuberous sclerosis complex.- Plusultra Pharma/Nobel
The CHMP has given a positive opinion for Hyftor (sirolimus topical gel) for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.
Facial angiofibroma is seen in approximately 75%-80% of TSC patients. Facial angiofibromas associated with TSC refer to facial skin lesions caused by genetic mutations resulting in unregulated cell growth. Without treatment, these may cause significant disfiguration, bleeding, pruritus and erythema.
The FDA has approved sirolimus topical gel (Hyftor) 0.2% for the treatment of facial angiofibroma in patients 6 years of age and older with tuberous sclerosis complex.
Learning Zones
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