Horizon Therapeutics’ Tepezza labeling adds warning about hearing loss

An FDA letter to Horizon Therapeutics dated July 17 indicated that the company’s supplemental biologics license application, or sBLA, was approved and provides for additions to the WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and PATIENT COUNSELING INFORMATION sections of the Prescribing Information. The Prescribing Information now states that Tepezza “may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”