Tricida Inc. has submitted a new drug application to the U.S. Food and Drug Administration under the accelerated approval program, seeking authorization for its drug veverimer to treat certain patients with chronic kidney disease.
If approved, veverimer, or TRC101, would treat metabolic acidosis in patients with chronic kidney disease.
Metabolic acidosis is when the body has accumulated too much acid and the patient's kidneys are unable to excrete enough acid or produce enough bicarbonate to balance the acid production. This condition, often caused by chronic kidney disease is believed to speed up the progression of kidney deterioration and increase the risk of muscle wasting and cause the loss of bone density.
According to the company's press release, it is estimated that metabolic acidosis will affect about 3 million patients with chronic kidney disease in the U.S., and there are no FDA-approved chronic therapies for its treatment.
The South San Francisco, Calif.-based pharmaceutical company's application is based on successful late-stage trials deeming the drug to be safe for long-term use to treat the disease.
"We now look forward to the potential approval and launch of veverimer next year," said Gerrit Klaerner, Tricida's CEO and president.
