FDA Approves Nobelpharma’s Topical Treatment for Facial Angiofibroma

The FDA has approved Nobelpharma’s Hyftor (sirolimus topical gel) for the treatment of patients six years or older with tuberous sclerosis complex-associated facial angiofibroma.

The approval was supported by positive results from a phase 3 trial in which 62 participants were randomized to receive either Hyftor or a placebo gel twice daily for 12 weeks. The study met its primary endpoint of reductions in the size and color of angiofibromas — benign tumors made up of blood vessels and connective tissue — at week 12.

An immunosuppressant drug, Hyftor was initially approved in 1999 as an oral treatment to prevent organ rejection in patients receiving renal transplants. It is the first FDA-approved topical treatment for facial angiofibroma.