The FDA approved Celgene-subsidiary Impact Biomedicines’ Inrebic (fedratinib) to treat patients with myelofibrosis, a rare bone-marrow cancer. The drug is only the second treatment for the disorder approved by the agency.
Inrebic is an oral capsule that was approved to treat adult patients with intermediate or high-risk forms of myelofibrosis. The drug requires a Boxed Warning about the risk of serious and fatal brain damage or malfunction.
The approval was based on a clinical trial that showed more than one third of patients who took the drug experienced a significant therapeutic effect and a decrease in symptoms, such as night sweats, itching and abdominal discomfort.