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Hyftor FDA Approval History

Last updated by Judith Stewart, BPharm on April 5, 2022.

FDA Approved: Yes (First approved March 22, 2022)
Brand name: Hyftor
Generic name: sirolimus
Dosage form: Topical Gel
Company: Nobelpharma America, LLC
Treatment for: Facial Angiofibroma Associated with Tuberous Sclerosis

Hyftor (sirolimus topical gel) is an mTOR inhibitor immunosuppressant indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.

  • Tuberous sclerosis complex (TSC) is a genetic disorder that causes tumors to form in various organs, including the skin. Approximately 75%-80% of TSC patients suffer from facial angiofibroma, which left untreated may cause significant disfiguration, bleeding, pruritus and erythema.
  • Facial angiofibromas associated with TSC are caused by aberrant activation of the mechanistic target of rapamycin (mTOR) pathway. Hyftor works by inhibiting mTOR activation.
  • Hyftor is applied to the skin of the face affected with angiofibroma twice daily.
  • Warnings and precautions associated with Hyftor include hypersensitivity reactions, serious infections, risk of malignancies, increased cholesterol and triglycerides, interstitial lung disease, reduced effectiveness of some vaccines, embryo-fetal toxicity, and male infertility.
  • Common adverse reactions include dry skin, application site irritation, pruritus, acne, acneiform dermatitis, ocular hyperemia, skin hemorrhage, and skin irritation.

Development timeline for Hyftor

Apr  4, 2022Approval FDA Approves Hyftor (sirolimus topical gel) for Facial Angiofibroma Associated with Tuberous Sclerosis

Further information

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