Clinuvel Pharmaceuticals Says FDA Removes Post-Authorization Requirement for Implant
Clinuvel Pharmaceuticals (ASX:CUV) said the US Food and Drug Administration (FDA) removed a requirement for a post-authorization phase one study on cardiac repolarization in relation to its Scenesse implant upon reviewing its long-term safety profile, according to a Monday filing with the Australian bourse.Scenesse is used to treat patients with erythropoietic protoporphyria, a disease that causes intolerance to light.The FDA concluded that the study was no longer needed since it would not yield valuable safety information, the filing said.