FDA approves Hyftor for facial angiofibroma in tuberous sclerosis complex

The FDA approved topical Hyftor for the treatment of facial angiofibroma in patients who have tuberous sclerosis complex, Nobelpharma America LLC announced in a press release.

Hyftor (sirolimus topical gel) 0.2%, which previously received orphan drug status, is the first topical treatment indicated for the treatment of facial angiofibroma in tuberous sclerosis complex.

A genetic disorder that causes tumors in many organs, tuberous sclerosis complex primarily affects the brain, eyes, heart, kidneys, skin and lungs. Approximately 75% to 80% of those with the disease will experience facial angiofibroma, according to the release.

“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," Yoshiki Kida, president and CEO of Nobelpharma America, said in the press release. "This landmark approval will bring a much-needed therapy to people with tuberous sclerosis complex."

According to the release, Hyftor will be available in the coming months in the U.S.