Novartis reports success in phase 3 trial of drug for rare kidney disease

Pharmaceutical maker and biotechnology company Novartis is reporting positive topline results from a phase 3 trial of a drug to treat a rare kidney disease.

Patients with the kidney disease, C3 glomerulopathy, who were taking 200 mg of iptacopan — also called Fabhalta — twice daily for six months were found to directly reduce the amount of protein in their urine when combined with background therapies. The drug’s safety profile was also consistent, according to the Dec. 11 news release. 

“People living with C3 glomerulopathy have no approved treatment options indicated for this progressive disease, posing many challenges and uncertainty for these mostly young patients,” Shreeram Aradhye, MD, the president of development and chief medical officer at Novartis stated. “These positive results demonstrate the potential of iptacopan to provide clinically meaningful benefit in C3G and add to our growing body of evidence that supports its use across multiple complement-mediated diseases.”

The company also just received FDA approval Dec. 5 for the drug, which was shown in separate trials to make improvement in the absence of transfusions as the first oral monotherapy for adults with a rare blood disease.

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