Calliditas Therapeutics Scores Complete FDA Approval, Broader Label For Lead Kidney Disease Drug

The FDA approved Calliditas Therapeutics AB's CALT Tarpeyo (budesonide) delayed-release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. 

Tarpeyo was first approved in December 2021 under accelerated approval based on the surrogate marker of proteinuria. 

Marking a significant milestone, Tarpeyo is now the first fully FDA-approved treatment for IgAN based on a measure of kidney function.

Tarpeyo (investigational name Nefecon) is the only FDA-approved IgAN treatment to reduce kidney function loss.      

Also Read: EXCLUSIVE: Kidney Care Revolution? How Swedish Biopharma Calliditas Aims To Tackle A Rare Disease With 'Unique, But Pretty Simple' Drug.

Tarpeyo is now approved with a confirmed and statistically significant benefit over placebo in estimated glomerular filtration rate (eGFR) over the two-year period that consisted of 9 months of treatment with Tarpeyo plus optimized renin-angiotensin system inhibitor (RASi) or placebo and optimized RASi and 15 months of follow-up off study drug.

Significant proteinuria reduction achieved with TARPEYO plus RASi at nine months was durable and maintained throughout the 15-month off-drug period.

Tarpeyo is available exclusively through Calliditas specialty pharmacy, Biologics, by McKesson Corporation MCK. 

Tarpeyo will continue to be priced at $15,123 per month, Reuters noted, compared to Travere Therapeutics Inc's TVTX Filspari, priced at $9,900 per month.

The full approval of Tarpeyo could "pave a way for a potential inflection point of its adoption in 2024," Reuters noted, citing an H.C. Wainwright analyst, adding the drug could generate net sales of about $224 million in 2024.

Roche Holdings AG RHHBY, Novartis AG NVS, Vera Therapeutics Inc VERA are among the companies developing IgAN treatment and are currently in mid-to-late stage development trials.

Price Action: CALT shares are up 14.40% at $25.72 during the premarket session on the last check Thursday.