April 10 Quick Takes: Postmarket trial results build case for Tepezza in broad population
Plus: June FDA panel to discuss Leqembi for full approval and updates from Sarepta, Clovis
New results from a Phase IV study of Tepezza teprotumumab-trbw from Horizon Therapeutics plc (NASDAQ:HZNP) strengthen the company’s case for the drug’s use in patients with chronic thyroid eye disease and low clinical activity scores (CAS). While the therapy’s approved label is broad, Horizon said on its 3Q22 earnings call that it had reached less than 3% market penetration in that population, which represents 80% of patients with moderate-to-severe TED who are typically seen by ophthalmologists and endocrinologists; it had achieved close to 20% penetration in high-CAS patients seen by ocular specialists. Amgen Inc. (NASDAQ:AMGN) is acquiring Horizon for $28.7 billion, gaining a growth driver in Tepezza that Horizon has said could reach more than $4 billion in peak annual sales.
FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee on June 9 to discuss the sBLA from Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB) for Leqembi lecanemab-irmb to treat early Alzheimer’s disease. FDA is reviewing the sBLA to convert the drug’s accelerated approval to full approval based on the confirmatory Phase III Clarity AD study. CMS currently restricts coverage of the drug to its use in clinical trials; it has said broader coverage would follow if Leqembi gains full approval. ...