Travere drug for rare kidney condition recommended for EU approval

Calliditas Therapeutics AB

23/02/2024 08:41

By Ludwig Burger
       Feb 23 (Reuters) - Vifor Pharma and partner Travere
Therapeutics  TVTX.O  on Friday won an endorsement for approval
from the European Union's drug regulator for their drug
Filspari, part of an industry race to treat a rare, serious
kidney condition known as IgAN.
    The regulator's opinion provides the basis for the European
Commission’s final decision, Vifor said in a statement.
    The pharma companies are competing to develop treatments for
IgAN, which is a progressive autoimmune disease that mostly
affects young adults and which can lead to kidney failure that
requires dialysis or organ transplantation. 
    Novartis  NOVN.S  last year acquired U.S. biotech firm
Chinook for up to $3.5 billion to bolster its work on therapies.
    Travere in early 2023 won accelerated approval from the U.S.
Food and Drug Administration for Filspari, or sparsentan, to
treat IgAN. Travere said in December it would be seeking full
U.S. approval. 
    Vifor Pharma owns exclusive commercialization rights  for
sparsentan in Europe and other markets.
    Calliditas Therapeutics'  CALTX.ST  IgAN drug Tarpeyo won
full U.S. approval in December 2023.

 (Reporting by Ludwig Burger
Editing by Mark Potter)
 ((ludwig.burger@thomsonreuters.com; +49 30 220133634;))