Swedish contrast media developer CMC Contrast has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its CMC-001 liver-specific contrast agent.
The Orphan Drug Designation was granted for the agent's use as a targeted contrast agent in diagnostic MRI for detection and localization of focal liver lesions in patients where gadolinium-based contrast agents are contraindicated or cannot be administered, according to the company.
The FDA designation confers special incentives, including tax credits toward the cost of clinical trials, prescription drug use fee waivers, and may entitle a period of seven years of U.S. market exclusivity upon FDA clearance, CMC said. The FDA's Office of Orphan Drug Products grants the Orphan Drug Designation to novel drugs intended to treat a rare disease or condition affecting fewer than 200,000 people in the U.S.
CMC said it's now planning a pivotal phase III clinical trial, which the company said will enable the agent to obtain regulatory approval and marketing authorization in the U.S.