EU Approves Takeda’s Injectable Entyvio for IBD

EU OK Follows FDA’s Recent Rejection Of The New Formulation

Takeda has won EU approval for an injectable version of Entyvio to treat ulcerative colitis or Crohn’s disease, in contrast to the FDA’s rejection in December.

Digestive_System
Injectable Entyvio EU approval is for ulcerative colitis and Crohn’s disease • Source: Shutterstock

The European Commission has given regulatory approval for a new subcutaneous formulation of Takeda Pharmaceutical Co. Ltd.'s blockbuster gastrointestinal drug Entyvio (vedolizumab) as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease.

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 New Products

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

 

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 

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

 

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

Moderna Punts On US Vaccine Policy Changes, Will Focus More On Cancer

 
• By 

On its Q1 earnings call, Moderna avoided criticizing policy changes affecting vaccines but de-emphasized its flu/COVID-19 vaccine for under-50 and prioritized cancer programs.

Zepbound Grows, But CVS/Novo Nordisk Deal For Wegovy Casts Shadow

 

Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.

Scrip M&A Podcast: Will FDA Staff Cuts Impact Biopharma Dealmaking?

 
• By 

Attorneys Andrew Goodman and Alan Minsk, as well as Naya CEO Daniel Teper, discussed the ramifications of US FDA staff cuts on M&A activity with Scrip senior writer Joseph Haas.