FDA Grants Orphan Drug Designation for the Treatment of Scleroderma
NORTH CHICAGO, Ill., April 11, 2024 /PRNewswire/ -- BLR Bio, an emerging biotechnology company in Rosalind Franklin University's Helix 51 biomedical incubator , announced that the U.S. Food and Drug Administration (FDA) granted an Orphan Drug Designation for its investigational therapy BLR-200 for the treatment of systemic sclerosis (SSc), also known as scleroderma.
- NORTH CHICAGO, Ill., April 11, 2024 /PRNewswire/ -- BLR Bio, an emerging biotechnology company in Rosalind Franklin University's Helix 51 biomedical incubator , announced that the U.S. Food and Drug Administration (FDA) granted an Orphan Drug Designation for its investigational therapy BLR-200 for the treatment of systemic sclerosis (SSc), also known as scleroderma.
- Orphan Drug Designation is granted by the FDA to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.
- "The FDA's granting of Orphan Drug Designation to BLR-200 highlights the urgent need for new and innovative therapeutic options for patients afflicted with the disease."
- Dr. Ronald Kaplan, RFU executive vice president for research, said the orphan designation represents an important milestone in the development of BLR Bio's drug candidate.