Hyftor

Hyftor can only be obtained with a prescription and is available as a gel that is applied twice a day to the areas of the face affected by angiofibroma. Treatment should be stopped after 12 weeks if there is no effect.

For more information about using Hyftor, see the package leaflet or contact your doctor or pharmacist.

The way in which Hyftor works in facial angiofibroma due to tuberous sclerosis complex is not fully understood. The active substance of Hyftor, sirolimus, works by blocking an enzyme called ‘mammalian target of rapamycin’ (mTOR). This enzyme is involved in the control of cell division and has increased activity in tumour cells in patients with tuberous sclerosis complex. By blocking mTOR, sirolimus stops tumour cells dividing, which is expected to reduce the growth of skin tumours associated with the disease.

A main study involving adults and children aged 6 years and above with facial angiofibroma due to tuberous sclerosis complex has shown Hyftor to be effective at improving facial angiofibroma. After 12 weeks, facial angiofibroma size and redness improved or greatly improved in 18 out of 30 patients (60%) who used Hyftor compared with none of the 32 patients (0%) who used a placebo gel (dummy treatment).

For the full list of side effects and restrictions with Hyftor, see the package leaflet.

The most common side effects with Hyftor (which may affect more than 1 in 10 people) include irritation at the application site, dry skin, acne and pruritus (itching).

Hyftor has been shown to improve the size and redness of facial angiofibroma due to tuberous sclerosis complex in adults and children aged 6 years and older, which are considered relevant benefits. The medicine’s safety profile is considered acceptable. The European Medicines Agency therefore decided that Hyftor’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hyftor have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Hyftor are continuously monitored. Suspected side effects reported with Hyftor are carefully evaluated and any necessary action taken to protect patients.

Hyftor received a marketing authorisation valid throughout the EU on 15 May 2023.

Further information on Hyftor can be found on the Agency’s website: ema.europa.eu/medicines/human/EPAR/hyftor.

This overview was last updated in 07-2023.