US FDA approves Sweden-based Calliditas' kidney disease drug

[December 21, 2023]  By Mariam Sunny and Christy Santhosh

(Reuters) -The U.S. Food and Drug Administration (FDA) granted full approval to Swedish drugmaker Calliditas Therapeutics' drug to treat rare kidney disease IgA Nephropathy (IgAN), the company said on Wednesday.

The company's U.S.-listed shares rose 29% after the bell.

The FDA decision makes the drug, branded as Tarpeyo, the first to be granted a full approval in the United States for IgAN, ahead of Travere Therapeutics' 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.

A full approval will help Tarpeyo gain access to a "significantly larger" patient population, Calliditas CEO Renee Lucander said ahead of the approval.

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.

Tarpeyo will continue to be priced at $15,123 per month, the company said, compared to Filspari that is priced at $9,900 per month.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File photo

The full approval of Tarpeyo could "pave a way for a potential inflection point of its adoption in 2024," H.C. Wainwright analyst Arthur He said ahead of the decision, adding that he estimated the drug to generate net sales of about $224 million in 2024.

The full approval of Calliditas' drug is based on data from a late-stage trial that showed significant improvement in filtration rate, an indicator of kidney health, compared to a placebo.

Roche, Novartis, Vera Therapeutics are among the companies working on a treatment for IgAN and are currently in mid-to-late stage development trials.

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

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