Nobelpharma’s Hyftor® (sirolimus) topical gel has been granted FDA approval to treat angiofibroma associated with tuberous sclerosis in patients who are at least three years old.

• Tuberous sclerosis is a rare genetic disorder that causes noncancerous but potentially life-threatening tumors. Most individuals diagnosed with the condition develop facial angiofibromas, which are growths made up of blood vessels and fibrous tissue.
• Hyftor is a topical formulation of sirolimus, a drug that first received FDA approval in 1999. Under the recommended dosing, it should be applied to the affected skin of the face twice daily. The maximum recommended daily dose is:
  • 600mg (2cm) for patients 6–11 years of age.
  • 800mg (2.5cm) for patients 12 years of age and older.
• Launch and pricing information are not yet available.