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.
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