Apellis To Try Again After EMA Rejects Geographic Atrophy Drug

The delayed decision from the CHMP is another rejection for Syfovre but Apellis still hopes the regulator may be convinced in a second review later this year.

Apellis

Apellis has received the bad news it has been expecting for some time as the European Medicines Agency’s expert committee has given a thumbs down to its geographic atrophy treatment Syfovre.

The ruling adds to Apellis’ difficulties with Syfovre (pegcetacoplan) in the US market, where sales of the complement C3 cyclic peptide inhibitor drug are still recovering from a safety scare....

Key Takeaways
  • Still overcoming safety concerns in the US, the EU knockback is another blow to Apellis’ plans.

  • The company believes the ruling could be...

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

More from Business

Summit’s Ivonescimab Shows Significance On PFS, But Not Overall Survival

 
• By 

In a study intended to show similar benefit in western patients, PD-1/VEGF-targeting ivonescimab met a progression-free survival endpoint, but missed on OS.

Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By 

One Phase III trial hits but a second study misses by a mile.

Astellas Gets CLDN.18.2-Targeted ADC From China’s Evopoint

 
• By 

Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.

All Over For iTeos But Applause For Plan To Return Cash Fast

 
• By 

The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.

More from Scrip

Quotables: Pharma Leaders On The Month’s Hot Topics

 

The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.

In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Astellas Gets CLDN.18.2-Targeted ADC From China’s Evopoint

 
• By 

Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.