PharmaEssentia announced yesterday that its new drug Ropeginterferon alfa-2b-njft (Ropeg, also known as P1101) pen injector (Pen Device) has completed the supplemental Biologics License Application (sBLA) submission to the U.S. FDA. The company expects the product to receive approval for market launch by February next year. Before the end of the year, PharmaEssentia also plans to submit an application for a new indication: essential thrombocythemia (ET).

Ropeg was first approved by the U.S. Food and Drug Administration (FDA) in 2021 for the treatment of polycythemia vera (PV). According to PharmaEssentia, the pen injector has been designed as single-use only, in line with FDA requirements, to prevent potential risks associated with reuse. This design not only enhances patient safety but also simplifies administration, making it more convenient, particularly for the older patient population, and is expected to improve medication compliance.

The Ropeg pen injector has completed preparations for commercial-scale production, and the company anticipates FDA approval for market launch in February next year. Since the FDA considers the pen injector as a new product, it is expected to allow for re-pricing, providing an additional revenue growth driver and a new engine for future business expansion.

Regarding the new indication for ET, PharmaEssentia completed Pre-sBLA communications with the FDA in September. The FDA confirmed that, given the completeness of the submitted data and clarity of the review direction, the company can proceed directly to the sBLA filing without holding a Pre-sBLA meeting. The FDA has also agreed to accept clinical data from the SURPASS ET and EXCEED ET studies as confirmatory evidence. PharmaEssentia plans to officially submit the U.S. ET application by the end of this year, targeting approval in 2026.

In addition to preparing the submission, PharmaEssentia is undertaking a comprehensive pre-launch strategy, including early-market access planning. The company has already begun communications and strategic discussions with insurance providers in preparation for product launch. Typically, market access preparation takes more than a year, but because this concerns an additional indication, the preparation timeline can be significantly shortened.

Resource: 藥華藥完成筆型注射器查登申請，目標明年2月獲准上市