Positive Opinion for Aldurazyme From CPMP

Published: 24-Feb-2003


The Committee for Proprietary Medicinal Products (CPMP) of the European Union has issued a positive opinion on BioMarin Pharmaceutical and Genzyme General's marketing application for Aldurazyme (laronidase), an investigational enzyme replacement therapy for treatment of mucopolysaccharidosis I (MPS I), a rare, progressive and debilitating genetic disorder.

The positive CPMP opinion is the final step before formal approval to market Aldurazyme in the 15 countries of the European Union. The companies have been advised that the committee's opinion will be forwarded to the European Commission, which is expected to make a final decision on marketing authorisation within three to four months. The Commission generally follows the advice of the CPMP, but it is not obliged to do so.

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