FDA grants Orphan Drug Designation for tasquinimod in myelofibrosis
Lund May 18, 2022 - Active Biotech AB (Nasdaq Stockholm: ACTI) today announced that the U.S. Food and Drug Administration (FDA) has granted tasquinimod Orphan Drug Designation for the treatment of myelofibrosis.
- Lund May 18, 2022 - Active Biotech AB (Nasdaq Stockholm: ACTI) today announced that the U.S. Food and Drug Administration (FDA) has granted tasquinimod Orphan Drug Designation for the treatment of myelofibrosis.
- The Orphan Drug Designation awarded by the FDA for tasquinimod in myelofibrosis represents an important step forward for Active Biotech, said Heln Tuvesson, CEO Active Biotech.
- The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnoses or prevention of rare diseases or disorders that affects fewer than 200,000 people in the U.S.
- Active Biotech and Erasmus MC have initiated a research collaboration with tasquinimod in myelofibrosis, that includes preclinical studies as well as a clinical proof of concept study in patients with myelofibrosis.