Novartis drug candidate scores interim win in rare kidney disease trial (updated)

Calliditas Therapeutics AB

30/10/2023 10:30

(Adds detail on kidney disease in paragraphs 3,10 and 11, on
rivals in paragraphs 7-9)
    By Ludwig Burger
       FRANKFURT, Oct 30 (Reuters) - Novartis  NOVN.S  said its
experimental drug atrasentan was shown to have a positive effect
on an indicator of kidney health in people suffering from a rare
type of kidney disease in an interim analysis of a late-stage
drug trial.
    Treatment with the drug candidate, acquired as part of the
purchase of U.S. biotech firm Chinook for up to $3.5 billion,
resulted in a meaningful improvement in proteinuria in patients
suffering from IgA nephropathy when compared to placebo, the
Swiss drugmaker said in a statement.
    Proteinuria is excess protein in the urine, which can be a
sign of the kidney failing to filter properly.
    Novartis, which is working on two other drug candidates to
treat IgAN, added it plans to review the interim results with
the U.S. Food and Drug Administration with a view to seeking
accelerated approval. 
        The trial will continue with more read-outs on kidney
function expected in the first quarter of 2026, the company
added.
  
        Novartis has become more dependent on its drug
development fortunes after it spun off its generic drugs
division Sandoz earlier this month.
  
        The prospect of treating IgAN has attracted a wide field
of contenders in drug development.
  
        
    Calliditas Therapeutics
      CALTX.ST  in August won priority review status from U.S.
regulators for its IgAN drug candidate.     Other companies
working on treatments include Roche  ROG.S  and Vera
Therapeutics  VERA.O . 
     TVTX.O  plunged last month after its drug, which had
already won accelerated approval in the United States, missed
key secondary goals in an IgAN trial. 
    IgAN is a progressive autoimmune disease that mostly affects
young adults and which can lead to kidney failure that requires
dialysis or organ transplantation. No targeted treatment options
are available.
    IgAN is among the most common causes of kidney failure in
young adults.    
    

 (Reporting by Ludwig Burger, editing by Rachel More and Jason
Neely)
 ((ludwig.burger@thomsonreuters.com; +49 30 220133634;))