Takhzyro Among Hopefuls For EU Approval Recommendation

A handful of companies are expected to find out this week whether their products will be recommended for EU approval. The EMA's drug evaluation committee, the CHMP, is due to give its opinion on marketing authorization on two orphan drugs for use in HAE and myotonia respectively, another biosimilar trastuzumab, and a flu vaccine.

Question
What will the CHMP decide this month? • Source: Shutterstock

Just a couple of months after securing US approval for its new treatment for the prevention of hereditary angioedema (HAE) attacks, Shire is due to find out this week whether lanadelumab (Takhzyro) is likely to be approved in the EU.

Takhzyro is one of two orphan-designated therapies whose initial marketing authorization applications are up for a recommendation from the European Medicines Agency’s drug

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 Europe

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By 

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Industry On Making England’s HTA Innovation Lab A Success

 

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

More from Geography

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By 

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Industry On Making England’s HTA Innovation Lab A Success

 

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.