United States – The U.S. FDA has approved the ingestion of Novartis’ (NOVN. S) drug to curb proteins in urine among patients with a certain type of kidney disease, the health regulator’s Website revealed on Wednesday.
The drug, called Fabhalta, is currently available to patients with paroxysmal nocturnal hemoglobinuria, which is a very rare blood condition in the adult population, as reported by Reuters.
With the new approval, Novartis’ drug has shifted to the IgA nephropathy (IgAN) segment, which poses a threat to Swedish firm Calliditas (CALTX). ST Tarpeyo and Filspari by Travere Therapeutics (TVTX. O).
Understanding IgAN Nephropathy
IgAN, which mainly occurs in young people, develops when antibody clumps accumulate within the kidneys, leading to inflammation that affects the small blood filtering units.
IgAN is expected to be worth USD 10 billion in the end says Guggenheim analyst Vamil Divan with more treatments available in the market.
Clinical Trial Success
The newest FDA approval came from a phase 3 clinical trial where Fabhalta demonstrated an efficacy of 43.8% decrease in the level of Proteinuria compared to the placebo.
They include Proteinuria, which is excess protein in the urine and may signal that the kidney is not working efficiently.
The Swiss drugmaker is also in the process of creating two other drugs which are still under trial, namely zigakibart and atrasentan for IgAN cure.
Future Developments from Novartis
IgAN’s chance is much higher with the other two drugs than with Fabhalta, Divan had said to Reuters before the FDA decision.
Other firms in this area are Otsuka (4768. T) and Vera Therapeutics (VERA. O), both of which are also developing treatments for the disease. As it was found earlier, in April, Vertex Pharmaceuticals (VRTX. O) had signed a deal for a USD 4.9 billion deal with Alpine Immune Sciences to get their experimental IgAN drug, as reported by Reuters.