Scienture's Arbli Losartan Oral Suspension Gets FDA Approval; Stock Up In Pre-market

(RTTNews) - Scienture Holdings, Inc. (SCNX), a holding company for existing and planned pharmaceutical operating companies, announced Tuesday that the U.S. Food and Drug Administration has approved SCN-102 with the brand name Arbli (losartan potassium) Oral Suspension, 10 mg/mL. Arbli is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.

Following a 66.4 percent surge on Monday on the Nasdaq, Scienture shares are currently gaining around 23.8 percent further in the pre-market activity to trade at $3.0700.

SCN-102 is being developed by Scienture Holdings' unit Scienture, LLC. The company expects to commercially launch and make Arbli available to patients in the U.S. in the third quarter.

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 a novel proprietary formulation of losartan, a proven therapy for treating hypertension.

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.

The company noted that 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.

Arbli comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 18 months from the date of manufacture when stored at room temperature, based on the data submitted in the NDA.

Once the 24-months stability data is submitted to the FDA, the shelf-life of the product is expected to be extended to 24-months at room temperature.

Arbli has two issued patents from the USPTO, which are also expected to be listed in the FDA Orangebook.

Shankar Hariharan, CEO of Scienture, LLC, said, "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."

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