FDA odobrava novi lokalni tretman za angiofibrome lica

Today the TSC Alliance® applauds the U.S. Food and Drug Administration’s (FDA’s) approval of HYFTOR™, which is the first FDA-approved topical treatment for facial angiofibromas in adults and children six years of age or older who have tuberous sclerosis complex (TSC). HYFTOR™, manufactured by Nobelpharma America, LLC, has Orphan Drug Status for this particular indication.      

“The TSC Alliance truly welcomes this topical treatment option for angiofibromas,” said Kari Luther Rosbeck, President & CEO of the TSC Alliance. “Since they often affect someone’s appearance and can cause bleeding, this treatment has the potential to truly reduce the impact of this manifestation on adults and children with TSC. We are thankful for Nobelpharma’s commitment to the TSC community.”

TSC is a rare genetic disease that causes non-cancerous tumors to form on or in vital organs, including the skin. Angiofibromas caused by TSC are small bumps usually scattered on the central face, especially on the nose and cheeks, and are often clustered in the grooves at the side of the nose. Angiofibromas are typically smaller than a peppercorn, but they can grow larger. They may be skin-colored, pink or red. Angiofibromas are found in a majority of individuals with TSC over 5 years of age and may easily bleed. They can also have adverse effects on appearance and self-image, prompting some individuals with TSC to avoid social situations.

“At the TSC Alliance’s 2017 Externally-Led Patient-Focused Drug Development meeting, we heard directly from individuals with TSC how risk of facial bleeding impaired their ability to participate in active sports,” said Steven L. Roberds, PhD, Chief Scientific Officer of the TSC Alliance, “We are hopeful this product will help more people live healthier and happier lives.”