FDA gives Orphan Drug Designation to Faron Pharmaceuticals’ Bexmarilimab

Betsy Goodfellow | August 29, 2023 | News story | Research and Development FDA, Faron, ODD, Oncology, leukemia 

Faron Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its bexmarilimab for acute myeloid leukemia (AML). The ODD will offer clinical development and commercialisation benefits that will ultimately strengthen the drug programme.

The drug is currently in a phase 1 study where it is being tested for the treatment of aggressive haematological malignancies of refractory AML – it works by targeting myeloid cell function and activating the immune system. Phase 2 initiation is expected to begin towards the end of 2023, along with the completion of dose escalation.

The FDA’s Office of Orphan Drug Products supports the development of treatments for rare disorders that affect fewer than 200,000 people in the US. With the ODD, Faron now has exemption of FDA application fees, market exclusivity upon regulatory approval and tax credits for qualified clinical trials.

Faron Pharmaceuticals is a clinical-stage biopharmaceutical company that aims to treat cancers through the use of novel immunotherapies.

The chief medical officer of the company, Dr Marie-Louise Fjällskog, commented: “ReceivingODD from the FDA signifies our continued progress and commitment to develop bexmarilimab as a potential treatment for AML. The designation represents a milestone in our development journey, one that we believe when combined with standard of care, will lead to better patient outcomes and improved quality of life.”

Rebecca Lee

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