- The European Commission has approved Calliditas Therapeutics' ( NASDAQ: CALT ) Kinpeygo (budesonide) for the treatment of immunoglobulin A (IgA) nephropathy in adults.
- Shares are up 9% in Friday afternoon trading.
- The drug was developed under the name Nefecon and will be marketed and launched in the European Economic Area by STADA Arzneimittel in this half of the year.
- The approval was based on data from the ongoing phase 3 NeflgArd study that is comparing Kinpeygo 16 mg once daily to placebo.
- The U.S. FDA gave the green light for the drug, known as Tarpeyo in the U.S., in December 2021 .
For further details see:
Calliditas Therapeutics wins European approval for Kinpeygo for IgA nephropathy