---
title: "PharmaEssentia Submits Supplemental BLA for BESREMi Label Expansion to FDA"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/269721996.md"
description: "PharmaEssentia Corporation has submitted a supplemental Biologics License Application to the U.S. FDA for BESREMi® label expansion to treat essential thrombocythemia, based on positive Phase 3 results. The submission includes the BESREMi® injection pen presentation. These submissions are under FDA review."
datetime: "2025-12-15T13:01:13.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/269721996.md)
  - [en](https://longbridge.com/en/news/269721996.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/269721996.md)
---

> Supported Languages: [简体中文](https://longbridge.com/zh-CN/news/269721996.md) | [繁體中文](https://longbridge.com/zh-HK/news/269721996.md)


# PharmaEssentia Submits Supplemental BLA for BESREMi Label Expansion to FDA

PharmaEssentia Corporation has submitted a supplemental Biologics License Application (BLA) to the U.S. FDA seeking label expansion for BESREMi® (ropeginterferon alfa-2b-njft) to include the treatment of essential thrombocythemia (ET), based on positive Phase 3 results. The company has also submitted the BESREMi® injection pen presentation to the FDA for review. These regulatory submissions are currently under review by the FDA. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PharmaEssentia Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20251215883518) on December 15, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)

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