In continuation of my update on losartan
Scienture Holdings, Inc. announced the U.S. Food and Drug Administration (FDA) approval of SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name Arbli (losartan potassium) Oral Suspension, 10 mg/mL. Arbli is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. Arbli is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.
Arbli is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. Arbli provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions. Arbli has two issued patents from the USPTO, which are also expected to be listed in the FDA Orangebook.
Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. Arbli is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. IQVIA data (MAT December 2024) indicates a total annual sales of approximately $292 million and a prescription volume of 68 million (TRx) for losartan in the US market.
“The approval of Arbli exemplifies our deep commitment to develop high value products that address unique and underserved patient needs. A significant number of patients can benefit from a safe and efficacious ready-to-use oral liquid formulation of losartan. We are excited with the approval of our first brand product which is part of our upcoming pipeline of novel specialty products,” remarked Shankar Hariharan, CEO of Scienture, LLC.
“We are pleased to bring to market, Arbli, a transformative therapy option containing losartan, one of the most widely prescribed molecules in its class, to patients, caregivers and healthcare professionals (HCPs). We expect to commercially launch and make Arbli available to patients in the U.S. in Q3 2025,” said Narasimhan Mani, President of Scienture, LLC.
“This announcement is extremely exciting and is a clear demonstration of the value Scienture, LLC brings to the combined company and its shareholders,” said Suren Ajjarapu, Chairman of the Board, Scienture Holdings, Inc.
No comments:
Post a Comment