Maia Pharmaceuticals said the U.S. Food and Drug Administration (FDA) has tentatively approved a new drug application (NDA) for its sincalide for injection, pending resolution of the firm's patent litigation with Bracco Diagnostics.
Maia's sincalide for injection is indicated for adults to stimulate gallbladder contraction, which may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals, according to Maia. It's also indicated for stimulating pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology. In addition, it is indicated for accelerating the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract, the firm said.
The tentative approval will be eligible for conversion to a final approval subject to the resolution of the patent litigation. Maia said it's confident the patent litigation will be resolved in its favor.
Bracco's Kinevac (sincalide for injection) is currently the only drug approved for the stimulation of gallbladder contraction and other conditions, but supply disruptions have led to shortages over the past five years.
