Topical sirolimus gel Hyftor has received marketing authorisation in the UK for TSC facial angiofibromas (growths and marks on the skin from TSC). This means UK decision-makers confirm that Hyftor has met their standards for safety, quality and benefit.
Hyftor is a gel that includes the medicine sirolimus, which is a type of medicine known as an mTOR inhibitor. We know that mTOR inhibitors can reduce the number and size of TSC-related growths in the body. Medicines for TSC include the mTOR inhibitors everolimus and sirolimus in tablet-form.
Currently, topical sirolimus (meaning sirolimus spread on the skin) has been available in only very specific circumstances in the UK. A small number of TSC clinics make their own creams and gels by crushing sirolimus tablets to form a paste. The clinic-created creams can be difficult to apply and uneven. With the marketing authorisation of topical sirolimus now set, it’s a big step towards a specific sirolimus gel available across the UK.
The TSA is working very closely with PlusUltra Pharma, the developor of Hyftor, to ensure that people with TSC can get access to topical sirolimus as soon as possible. We’ll share more information as soon as we have it.
