1. Scrip
  2. >>New Products

BioMarin Expands PKU Dominion With EU Approval Of Palynziq

 
• By Eleanor Malone

Palynziq has received European Commission approval to treat phenylketonuria a year after the US FDA gave it the green light. BioMarin now markets the only two approved treatments for the condition.

Green bicycle and pedestrian traffic lights, seen in Braunschweig, Germany - Image
BioMarin has got the EU green light for its second PKU treatment

BioMarin Pharmaceutical Inc. has received approval for Palynziq (pegvaliase) to treat adults with the rare disease phenylketonuria (PKU) in the European Union. The injectable pegylated recombinant enzyme product is the first enzyme substitution therapy for the condition, and was approved in the US in May 2018. BioMarin markets the only two products approved for PKU in the US and EU.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
• By Jessica Merrill

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Merck KGaA Seals SpringWorks Buy

 
• By Kevin Grogan

The German group is paying $3.9bn to get hold of the US firm and its two approved products.

Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 
• By Dexter Jie Yan

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.

More from Scrip

Zelluna Believes Its TCR Tech Can Unlock Natural Killer Cell Potential

 
• By Andrew McConaghie

While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.