---
title: "GSK's $4 Billion Asthma Drug Gets First-Ever Green Light in Europe"
type: "News"
locale: "zh-HK"
url: "https://longbridge.com/zh-HK/news/269559304.md"
description: "GSK's asthma drug, depemokimab, received its first global regulatory endorsement from Europe's drug regulator, recommended as an add-on therapy for severe asthma and chronic rhinosinusitis with nasal polyps. The drug showed a 54% reduction in serious asthma attacks and requires dosing only twice a year. GSK plans to launch it between 2026 and 2027, potentially generating $4 billion in annual sales, pending final approval from the European Commission expected in early 2026."
datetime: "2025-12-12T18:53:53.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/269559304.md)
  - [en](https://longbridge.com/en/news/269559304.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/269559304.md)
---

> 支持的語言: [简体中文](https://longbridge.com/zh-CN/news/269559304.md) | [English](https://longbridge.com/en/news/269559304.md)


# GSK's $4 Billion Asthma Drug Gets First-Ever Green Light in Europe

Analysts are increasingly focusing on GSK after Europe's drug regulator delivered what could be a pivotal endorsement for depemokimab, a treatment positioned for severe asthma and a common nasal condition. Following a review by the European Medicines Agency's human medicines committee, the regulator issued a positive opinion recommending depemokimab as an add-on therapy for patients with severe asthma associated with type 2 inflammation, as well as for those with chronic rhinosinusitis with nasal polyps who remain inadequately controlled on existing treatments. The recommendation represents the first such global regulatory backing for the drug and has drawn attention to its potential commercial trajectory.

Data assessed by regulators showed depemokimab reduced serious asthma attacks in adults and adolescents by 54% compared with placebo, while a separate study indicated reductions in nasal obstruction and polyp size in patients with chronic rhinosinusitis with nasal polyps. Observers have highlighted the drug's ultra-long-acting profile, which requires dosing only twice a year, as a feature that could support differentiation within respiratory and immunology markets if the therapy secures final approval.

GSK has previously indicated that depemokimab could be a key contributor to growth over the next few years, with plans to launch the medicine across multiple indications between 2026 and 2027. The company has said the drug could generate up to 3 billion, or around $4 billion, in annual sales, although that outcome will depend on regulatory progress and market uptake. Attention is now turning to the European Commission, which is expected to decide on approval in the first quarter of 2026, a milestone that could shape investor expectations for GSK's medium-term pipeline.

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- [GSK (GSK.US)](https://longbridge.com/zh-HK/quote/GSK.US.md)
- [GlaxoSmithKline plc (GSK.UK)](https://longbridge.com/zh-HK/quote/GSK.UK.md)

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