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FDA Grants Certa Therapeutics’ FT011 Orphan Drug Designation


Investigational therapy indicated for the treatment of systemic sclerosis.

Systemic sclerosis diagnosis concept, hands of a doctor and a patient are visible with diagnosis machinery. Image Credit: Adobe Stock Images/CesareFerrari

Image Credit: Adobe Stock Images/CesareFerrari

Certa Therapeutics revealed in a company press release that the FDA has permitted orphan drug designation for FT011, its investigational therapy for the treatment of systemic sclerosis (scleroderma). This designation is granted for investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US.

"We are very pleased that the FDA has granted Orphan Drug Designation to FT011 which we believe highlights the urgent need for innovation and new therapeutic options for scleroderma patients" said Darren Kelly, CEO, founder, Certa Therapeutics. "This designation represents an important milestone in the development of FT011, which has the potential to establish first-in-class clinical benefits by precisely targeting the root cause of fibrosis and offer treatment across multiple organs within these patients."

Reference: Certa Therapeutics' FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis. PR Newswire. October 23, 2023. Accessed October 24, 2023. https://www.prnewswire.com/news-releases/certa-therapeutics-ft011-granted-us-fda-orphan-drug-designation-for-the-treatment-of-systemic-sclerosis-301961921.html

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