BRIEF—Breakthrough Therapy Designation for avexitide

Rare disease specialist Eiger BioPharmaceuticals has been granted Breakthrough Therapy Designation for avexitide for the treatment of post-bariatric hypoglycemia (PBH), a serious condition occurring in post-bariatric surgical patients.

Avexitide is a targeted, first-in-class, GLP-1 antagonist, which has been dosed in 54 patients across four Phase II studies in PBH. It has Orphan Drug status in the USA and in Europe, in related indications.

Chief executive David Cory said: "We look forward to continued collaboration with the FDA, now on three Breakthrough Therapy Designation programs including lonafarnib for hepatitis delta virus (HDV) infection, lonafarnib for Hutchinson-Gilford Progeria Syndrome (Progeria) and Progeroid Laminopathies, and avexitide for post-bariatric hypoglycemia (PBH)."