US FDA approves Servier’s brain tumor treatment, Health News, ET HealthWorld

[Pelican Press 0]

This is the hidden content, please

• Sign In
• or
• Sign Up

US FDA approves Servier’s brain tumor treatment, Health News, ET HealthWorld

data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

London: Servier Pharmaceuticals said on Tuesday the U.S. Food and ***** administration has approved the French drugmaker’s treatment for a type of brain tumor, making it the first ***** to get a U.S. approval for the condition.

The *****, branded as voranigo, is used to treat a form of brain *******, called Grade 2 IDH-mutant glioma, in patients who have had surgery.

Gliomas, types of brain ******* that can hinder normal brain function, are so far only treated through the removal of the tumor. Grade 2 IDH-mutant glioma is caused by mutations in a family of genes called isocitrate dehydrogenase or IDH.

Voranigo was approved on the basis of a late-stage trial, where patients who took the treatment showed progression-free survival of 27.7 months compared to 11.1 months with the placebo group.

In the U.S., about 0.7 of every 100,000 people suffer from IDH-mutant glioma.

With the approval, Agios Pharmaceuticals will receive up to $1.1 billion in milestone payments from Servier and Royalty Pharma.

In 2021, Agios sold its oncology business to Servier and received $1.8 billion in upfront cash. It was also set to get a $200 million milestone payment upon the FDA approval of voranigo and 15% royalties on the *****’s potential U.S. net sales.

In May this year, Agios sold some of its voranigo royalty rights to Royalty Pharma. Under the terms of the agreement, an FDA approval for the ***** would trigger a payment of $905 million to Agios. (Reporting by Christy Santhosh; Editing by Shilpi Majumdar)

• Published On Aug 7, 2024 at 07:00 AM IST

Join the community of 2M+ industry professionals

Subscribe to our newsletter to get latest insights & analysis.

data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

Download ETHealthworld App

• Get Realtime updates
• Save your favourite articles

data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

Scan to download App
data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

This is the hidden content, please

• Sign In
• or
• Sign Up

#FDA #approves #Serviers #brain #tumor #treatment #Health #News #HealthWorld

This is the hidden content, please

• Sign In
• or
• Sign Up

This is the hidden content, please

• Sign In
• or
• Sign Up