Santhera’s Vamorolone For DMD Among Orphan Drugs Up For EU Marketing Decision

The European Medicines Agency is this week due to decide whether to recommend pan-EU marketing authorization for a number of new products.

An EMA Approval Recommendation Is Imminent For Several New Drugs • Source: Shutterstock

Santhera Pharmaceuticals could soon find out whether its Duchenne muscular dystrophy drug vamorolone will be recommended for EU marketing approval by the European Medicines Agency, paving the way for the product to become the bloc’s first treatment with a full marketing authorization for the condition.

Vamorolone, a first-in-class synthetic steroid, is one of eight new products that are up for an opinion this week on whether they should be approved, according to the

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from Approvals

More from Product Reviews

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By 

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.