Nobelpharma’s Hyftor Receives the US FDA’s Approval for the Treatment of Facial Angiofibroma in Patients with TSC
Shots:
- The approval was based on a P-III study evaluating Hyftor 0.2% vs vehicle in 62 patients aged ≥6yrs. with facial angiofibroma associated with TSC for 12wks.
- The results demonstrated improvement from baseline in size & redness of facial angiofibroma. An assessment of improved or markedly improved showed a 50% & 75% reduction in size and a 2 & 3-level reduction in redness, 23% vs 6% were improved/markedly improved, 13% vs 35% were improved & 10% vs 3% were markedly improved
- Hyftor is supplied in 10g tubes containing 2mg of sirolimus/gram with expected availability in the US in the coming mos. The company plans to provide patient support programs to help eligible patients with the treatment
Ref: PR Newswire | Image: Nobelpharma
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