Calliditas, already with first drug in U.S. to treat Berger's disease, gains same nod in Europe

Seven months after gaining approval for its immunoglobulin A (IgA) nephropathy drug in the United States, Swedish biotech Calliditas has won a nod for the same treatment closer to home.

On Monday, the European Commission granted marketing authorization to Kinpeygo for the disorder which causes a backup of the IgA antibody in the kidneys, resulting in inflammation and a hindering the kidneys’ ability to filter out waste.

The oral drug—blessed on an accelerated basis by the FDA and known in the U.S. as Tarpeyo—is the first to treat the condition, which is also known as Berger’s disease. Kinpeygo for adults at risk of progression to severe disease who have a specific urine protein-to-creatinine ratio. More than 50% of patients progress to end-stage renal disease.

In Europe, the drug will be marketed by Calliditas’ commercial partner Stada. That company plans a launch in the second half of this year.

European regulators endorsed the drug based on a study that showed Kinpeygo reduced proteinuria by 31% from baseline compared to 5% for placebo.

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Orphan drug specialist Calliditas is the first to the market with a Berger’s disease treatment, but others are likely on the way. Last month, Alnylam posted data for its Regeneron-partnered drug cemdisiran that showed a 37% mean reduction in the urine protein-to-creatinine ratio, compared with placebo.   

In addition, two months ago, Trevere Therapeutics gained priority review for its candidate sparsentan. Other companies with treatments on the way for the disorder are Chinook, Omeros, Novartis and a collaborative effort from Visterra and Otsuka.

Patients with Berger’s disease have historically been typically treated with steroids and hypertension-control drugs.