Pegasys receives positive opinion in EU

Published: 31-Jan-2005

The EU Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for Roche's Pegasys (peginterferon α-2a (40KD)) in the treatment of chronic hepatitis B.


The EU Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for Roche's Pegasys (peginterferon α-2a (40KD)) in the treatment of chronic hepatitis B.

The decision, granted for both types of the disease - HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) - will see a recommendation go to the EU Commission for final approval.

Pegasys, already the worldwide market leader in hepatitis C, works with a dual mode of action, stimulating the immune system as well as inhibiting virus replication. This offers physicians a new option with the advantages of a finite treatment duration and lasting remission from the disease, avoiding the burden of putting their patients on a life-long therapy.

'Studies have shown that Pegasys offers the best chance for a sustained response, in a defined treatment period, for chronic hepatitis B patients,' said Professor Patrick Marcellin, hepatologist at Hopital Beaujon, Clichy, France.

The CHMP positive opinion was based on one of the largest clinical development programmes in chronic hepatitis B, which included three global studies in more than 1,500 patients from 19 countries.

  

See more

You may also like

Medical Devices

Syensqo introduces medical-grade Amodel PPA for single-use, high-temperature medical devices

Read more
A new medical-grade Amodel PPA delivers high heat resistance, electrically insulative properties, and biocompatibility for advanced single-use medical instruments and assemblies

Trending Articles

  1. Continuous innovation: redefining the future of pharmaceutical manufacturing In an industry in which reliability is paramount and change can be slow, GEA has consistently proven that innovation and stability go hand in hand. Almost two decades ago, GEA introduced the first ConsiGma® continuous manufacturing (CM) system to the pharmaceutical market — a pioneering move that helped to reshape how oral solid dosage (OSD) forms are developed and produced
  2. Abselion launches AAVX and AAV9 Total Capsid Quantification Kits Ready-to-use solution for Amperia benchtop platform supports rapid, reliable quantification across a range of serotypes
  3. diaago and Peak Analysis & Automation partner to bring practical automation solutions to research laboratories Using diaago's customer-first approach with PAA’s decades of expertise in laboratory robotics, the collaboration promises to deliver solutions to streamline workflows, boost throughput and reduce bottlenecks
  4. Suncombe and Kindeva collaborate to deliver low-carbon inhalers to the NHS The partnership will develop next-generation pressurised metered-dose inhalers with low Global Warming Potential propellants, helping the NHS move closer to its Net Zero target
  5. Douglas Pharmaceuticals sets new benchmark for capsule quality with CI Precision Partnership delivers compliance confidence, efficiency gains and reduced waste

Upcoming event

Enhancing probiotic stability through smarter formulation and packaging strategies

18 September 2025 | Virtual See all

You may also like

Medical Devices

Syensqo introduces medical-grade Amodel PPA for single-use, high-temperature medical devices

A new medical-grade Amodel PPA delivers high heat resistance, electrically insulative properties, and biocompatibility for advanced single-use medical instruments and assemblies
Manufacturing

Sapio Sciences introduces world’s first 3rd-generation ELN

Sapio ELaiN is an AI-powered lab notebook designed to act as a scientific collaborator
Manufacturing

Signal Group launches MCERTS approved VOC emissions monitor

New SOLAR CEMNEX analyser offers advanced compliance and connectivity features
Research & Development

Genoskin raises $8.7m in its first funding round to advance its ethical, human-based alternatives to animal testing

The financing will drive Genoskin’s next phase of growth, with a view to scaling up operations in both the US and France
You need to be a subscriber to read this article.
Click here to find out more.
Packaging

Cloud labelling and serialisation: the new frontline of traceability in drug delivery

As drug delivery evolves to accommodate a new wave of data-driven innovation, the need for traceability and compliance throughout the supply chain is paramount. Innovative cloud-based solutions enable pharmaceutical companies to navigate these demands with confidence
Manufacturing

Sharp boosts autoinjector and pen assembly line capability with $20m investment in Pennsylvania facility

The money will boost its autoinjector and pen assembly, labelling and packaging lines across various therapeutic areas at its facility in Macungie, meeting the rising demand for injectables
Manufacturing

L.B. Bohle to showcase machines for OSD, food and nutraceuticals at PACK EXPO 2025

Company to present advanced blending, particle sizing and coating technologies at Las Vegas event
Subscribe now