Research-based pharmaceutical company Camurus has received a Complete Response Letter (CRL), i.e. a request for additional information from the US Food and Drug Administration (FDA) regarding the application for marketing authorization for CAM2029 for the treatment of acromegaly. This is stated in a press release.

The decision is said to be related to deficiencies identified during an inspection of a contract manufacturer's facility. The request includes new additional remarks, for example related to clinical efficacy or safety data for CAM2029.

"The FDA's decision is regrettable. Our application for marketing authorization is supported by strong clinical data demonstrating the potential of CAM2029 to address important unmet medical needs for patients with acromegaly. Camurus will work with the FDA and the contract manufacturer to make CAM2029 available to patients with acromegaly as soon as possible," said Fredrik Tiberg, CEO of Camurus.