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Orphans Elahere, Hetronifly & Hympavzi Among Eight New Products Set For EU Approval

 
• By Eliza Slawther

The European Medicines Agency has recommended the pan-EU approval of three rare disease drugs: Pfizer’s Hympavzi, Henlius Biotech’s Hetronify and ImmunoGen’s Elahere in addition to five other new medicines.

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Henlius Biotech’s Hetronifly (serplulimab) could soon be authorized for use in EU patients with extensive-stage small cell lung cancer (ES-SCLC) after the European Medicines Agency’s human medicine advisory committee, the CHMP, recommended its approval during its latest monthly meeting.

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More from Europe

Semaglutide For MASH Among Raft Of New EU Filings

 
• By Neena Brizmohun

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
• By Francesca Bruce

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
• By Francesca Bruce

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

More from EU CHMP

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
• By Neena Brizmohun

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 
• By Francesca Bruce

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.