MHRA approves Hyftor for the treatment of facial angiofibroma associated with tuberous sclerosis complex
Nobelpharma said that UK regulatory authorities have granted approval for Hyftor (sirolimus topical gel) for the treatment of facial angiofibroma associated with tuberous sclerosis complex (TSC) in adults and pediatric patients aged six years and older
The UK approval was given the same day by the Medicines and Healthcare products Regulatory Agency (MHRA). In the country, the product will be marketed by German subsidiary Plusultra pharma.
According to the company, Hyftor is the first topical gel agent indicated to treat TSC-associated facial angiofibroma. In Japan, where it is known as Rapalimus Gel, the drug was designated for the sakigake fast-track pathway and launched in June 2018. It was rolled out in the US in August 2022, while approval was granted in China in March and in Europe on 15 May 2023. with the drug expected to hit the region through German partner Plusultra pharma.
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