Innovative IgA Nephropathy Therapy Receives Accelerated FDA Approval

A few days ago, Calliditas Therapeutics announced that the US FDA approved budesonide (Budesonide, English trade name: Tarpeyo) sustained-release capsules for the treatment of adult patients with primary immunoglobulin A (IgA) nephropathy who are at risk of rapid disease progression

IgA nephropathy is the main cause of chronic kidney disease and renal failure.

As a targeted release oral preparation, budesonide uses Calliditas' TARGIT technology to allow the drug to pass through the gastrointestinal tract without being absorbed, and only be absorbed when it reaches the lower part of the small intestine

This approval is based on positive data obtained from a phase 3 clinical trial

Reference materials:

[1] FDA approves first drug to decrease urine protein in IgA nephropathy, a rare kidney disease.

[2] FDA grants Calliditas Therapeutics Accelerated Approval of TARPEYO™ (budesonide) to Reduce Proteinuria in IgA Nephropathy.

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