Pharos iBio, a company specializing in the development of innovative drugs based on artificial intelligence (AI), announced on the 24th that its drug candidate 'PHI-101' for treating acute myeloid leukemia (AML) has received orphan drug designation from the European Medicines Agency (EMA).
PHI-101 is an innovative anti-cancer drug candidate derived through Pharos iBio's artificial intelligence (AI) drug development platform 'Chemiverse'.
The company expects PHI-101 to benefit from reduced new drug approval review periods, clinical trial-related consultations, and a 10-year market exclusivity period after approval, now that it has been designated as an orphan drug in Europe. Previously, PHI-101 was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) in 2019 and received development-stage orphan drug designation from the Korean Ministry of Food and Drug Safety last year.
Acute myeloid leukemia is a rare and difficult-to-treat disease that requires new therapies due to its high recurrence rate and drug resistance limitations.