FDA OKs Calliditas' kidney disease drug

 The U.S. Food and Drug Administration granted full approval to Swedish drugmaker Calliditas Therapeutics' 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' 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. 

https://finance.yahoo.com/news/1-us-fda-approves-sweden-213012228.html