US FDA approves Sweden-based Calliditas' kidney disease drug (updated)

Calliditas Therapeutics AB

20/12/2023 21:30

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       Dec 20 (Reuters) - The U.S. Food and Drug Administration
granted full approval to Swedish drugmaker Calliditas
Therapeutics'  CALTX.ST  drug to treat rare kidney disease IgA
Nephropathy (IgAN), the company said on Wednesday.
    The decision makes the drug, branded as Tarpeyo, the first
drug to be granted a full approval in the United States for
IgAN, ahead of Travere Therapeutics'  TVTX.O  rival, Filspari,
which won accelerated approval earlier this year.
    The health regulator, in 2021, granted accelerated approval
to Tarpeyo, for adults with primary IgAN to reduce increased
protein levels in the urine, a condition called proteinuria.
    IgAN, also known as Berger's disease, occurs when a type of
antibody deposit builds up in the kidneys, causing inflammation
that damages its tiny filtering units.
    The disease affects about 130,000–150,000 people in the
United States, according to the company.

 (Reporting by Mariam Sunny, Christy Santhosh and Sriparna Roy
in Bengaluru; Editing by Shinjini Ganguli and Shounak Dasgupta)
 ((Christy.Santhosh@thomsonreuters.com))