FDA approves first topical treatment for facial angiofibroma associated with tuberous sclerosis

BETHESDA- The Food and Drug Administration has approved sirolimus 0.2% gel (Hyftor) as the first topical treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC) among 6 years and older.HYFTOR™ has Orphan Drug status for this indication.

"The U.S. approval of HYFTOR™ is a significant milestone for Nobelpharma. Not only is this our first FDA approval, but it is also the first ever FDA-approved topical treatment for facial angiofibroma associated with tuberous sclerosis complex," said Yoshiki Kida, President & CEO of Nobelpharma America. "This landmark approval will bring a much-needed therapy to people with tuberous sclerosis complex."

Tuberous sclerosis is a genetic disorder that causes tumors to form in various organs, primarily the brain, eyes, heart, kidneys, skin, and lungs, and continues over the lifetime of those who have it. Facial angiofibroma has typically been defined by skin lesion caused by unregulated cell growth and has been known to occur in 75-80% of patients with TSC.Approximately 50,000 people in the US alone have TSC, with an estimated 40,000 having TSC-related facial angiofibroma as well. Many of these cases have been diagnosed in children.