European Commission approves SCENESSE
Tuesday, 23 December 2014 10:38
Commercial distribution in preparation for European EPP patientsClinuvel Pharmaceuticals Ltd (ASX:CUV; XETRA-DAX: UR9; ADR: CLVLY) announced today that the European Commission has ratified the recommendation of the European Medicines Agency (EMA), granting marketing approval under exceptional circumstances to Clinuvel’s breakthrough drug SCENESSE® (afamelanotide 16mg).
Clinuvel is now allowed to market SCENESSE® for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) across the 31 EMA counties1. EPP is defined as the most severe clinical form of light and sunlight intolerance, often described as anaphylaxis to indoor and outdoor light sources. EPP patients are characterised by a lifelong fear of light, leading to a reclusive existence starved of daylight.
“Our objective has long been to provide EPP patients who are chronically deprived of light with a meaningful therapy to enable them to lead a normal existence free of impediment or psychological encumbrance,” Clinuvel’s CEO, Dr Philippe Wolgen said. “Now the Clinuvel teams will focus on accelerating distribution of SCENESSE® while continuing to reach agreements with individual and collective insurers to provide national coding for a completely new pharmaceutical treatment.”
“We are the first drug developer in a novel field of medicine providing these patients the ability to lead a disease-free and normal existence, without fear of severe burns and scarring, in accordance with the EU’s Charter of Fundamental Rights,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “The persistent strong demand from European and US EPP patients indicates that SCENESSE® is, for the first time, providing patients an opportunity to fully participate in society and lead a life without handicap.”
Clinuvel will first focus on rolling out SCENESSE® in the eight countries across Europe where EPP clinical trials were conducted, with other countries to follow thereafter. Discussions are underway with government bodies and reimbursement authorities to enable patient access through expert national reference centres for porphyrias.
“Since the landmark opinion from the EMA two months ago the Company has been preparing for commercialisation in key markets in Europe,” Dr Wolgen said. “EPP patients are particularly light deprived and are at risk of burns during the spring and summer months. Clinuvel aims to facilitate access to the drug to as many of the known EPP patients as possible in 2015, and much will depend on the administrative duties with Competent Authorities and payors in each European country.”
“I take the opportunity to publicly commend the two EMA rapporteurs and their teams for seeing through a challenging dossier and for their support in bringing pharmaceutical innovations to the European markets. On occasions our teams have challenged the EMA but we need to acknowledge the vision and their leadership when it comes to supporting novel developments in medicine,” Dr Wolgen said.
As part of the exceptional circumstances approval, Clinuvel is establishing a post-marketing program to monitor ongoing patient safety and efficacy, including the establishment of patient and disease registries. A Phase IV pharmacokinetic study in 12 EPP patients (CUV052) will also be conducted according to the Pharmacovigilance Plan developed by Clinuvel and the EMA. In line with article 14(8) of Regulation (EC) No 726/2004, Clinuvel will submit a Periodic Safety Update Report to the EMA to comply with the Company’s obligations as part of the marketing authorisation under exceptional circumstances.
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1 28 European Union member states plus Iceland, Liechtenstein and Norway. |
