Aug 6 (Reuters) - Servier Pharmaceuticals said on
Tuesday the U.S. Food and Drug administration has approved the
French drugmaker's treatment for a type of brain tumor, making
it the first drug to get a U.S. approval for the condition.
The drug, branded as voranigo, is used to treat a form of
brain cancer, called Grade 2 IDH-mutant glioma, in patients who
have had surgery.
Gliomas, types of brain cancer 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 ( AGIO ) will
receive up to $1.1 billion in milestone payments from Servier
and Royalty Pharma ( RPRX ).
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 drug's potential U.S. net sales.
In May this year, Agios sold some of its voranigo royalty
rights to Royalty Pharma ( RPRX ). Under the terms of the agreement, an
FDA approval for the drug would trigger a payment of $905
million to Agios.