US FDA approves Novartis' kidney disease drug (updated)

Calliditas Therapeutics AB

07/08/2024 19:33

(Adds details paragraph 2 onwards)
       Aug 7 (Reuters) - The U.S. Food and Drug Administration
has approved the use of Novartis'  NOVN.S  drug to reduce excess
protein in the urine of patients with a type of kidney disease,
the health regulator's website showed on Wednesday.
    The drug, Fabhalta, is already approved to treat adults with
paroxysmal nocturnal hemoglobinuria, a rare blood disorder.
    With the expanded approval, Novartis' drug entered the IgA
nephropathy market and will compete with Swedish drugmaker
Calliditas'  CALTX.ST  Tarpeyo and Travere Therapeutics'
 TVTX.O  Filspari.
    Guggenheim analyst Vamil Divan sees the IgAN market valuing
at $10 billion over time as more treatments comes to market.
    IgAN occurs when clumps of antibodies are deposited in
kidneys, causing inflammation that damages its tiny filtering
units.

 (Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi
Majumdar)
 ((Sriparna.Roy@thomsonreuters.com))