Thursday, October 27, 2016

Clinuvel Information

CLINUVEL PHARMACEUTICALS LTD [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that it will meet with the US Food and Drug Administration (FDA) on 7 November to formally discuss lodging its new drug application (NDA) for the novel drug SCENESSE® (afamelanotide 16mg). The pre-NDA meeting will focus on finalising requirements for filing SCENESSE® with the FDA for the treatment of adult patients with the rare genetic disorder erythropoietic protoporphyria (EPP). 

“This is the last step required of CLINUVEL before we ask the FDA to review the risk-benefit profile of SCENESSE
® in a submitted dossier,” CLINUVEL’s Acting Chief Scientific Officer, Dr Dennis Wright said. “A successful risk-benefit review will enable CLINUVEL to make the drug available to US EPP patients.”

The pre-NDA meeting, with the FDA’s Division of Dermatology and Dental Products (DDDP), is part of ongoing dialogue between CLINUVEL and the FDA since CLINUVEL commenced a clinical program for EPP in 2006. 

Earlier this year the FDA granted SCENESSE
® Fast Track designation, enabling – among other benefits – a rolling review of the NDA dossier. The FDA also completed an initial review of CLINUVEL’s clinical data package, deeming it satisfactory and sufficient for NDA submission. On 24 October the DDDP will host an EPP Workshop to obtain the patients’ and physicians’ perspective on certain disease areas, including the effectiveness of treatments.

SCENESSE
® is the first treatment ever evaluated in contemporary clinical trials for EPP. The drug provides photoprotection to EPP patients who suffer from acute reactions to visible light and sun (phototoxicity). In 2014 SCENESSE® was approved in Europe for the prevention of phototoxicity in adult EPP patients, with the drug now prescribed in a number of European countries.
 
“It has always been our goal to make the drug available to US EPP patients, and it has become more pressing now that the drug is available in Europe,” CLINUVEL’s Global Director, Regulatory Affairs, Ms Nicoletta Muner said. “In recent months our dialogue with the FDA has intensified as the agency sought to learn more about our program and as the product is being distributed internationally. We look forward to the next steps in the review of SCENESSE
®.”

                                  "Remember....Research is the key to your cure!"

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