Clinuvel gets pre-approval win in Italy

Italy's National Health System has bucked the European regulatory system and approved the use and reimbursement of Clinuvel's photoprotective drug, afamelanotide, prior to it gaining regulatory approval in Europe or the US.

This means patients who suffer from the rare disorder, erythropoietic protoporphyria (EPP) - for which there is no current treatment besides minimising exposure to sunlight - can be prescribed afamelanotide by Italian physicians, and the full cost will be reimbursed by Sistema Sanitario Nazionale, the Italian national health system.

Clinuvel has offered afamelanotide under 'compassionate use' in the past to patients following the end of clinical trials in Australia and the United Kingdom.

A similar arrangement was to be done in Italy, except Clinuvel arranged with the Italian regulators to reimburse the company for the compassionate use programme.

“Following the completion of the complex study of afamelanotide in Italian EPP patients, we continued to support their treatment through a compassionate use program," said Dr Philippe Wolgen, Clinuvel’s CEO.

"Unfortunately, the indefinite free supply of afamelanotide was not sustainable for Clinuvel as a small enterprise, and this approval by the Italian regulators not only makes the drug available to these trial patients, but also provides further incentive to the company to focus on orphan drug development.”

Italian law contains a provision to allow for the approval and reimbursement of drugs that treat conditions for which not alternative therapy exists, and when that drug is still in clinical development.

36 drugs have already been approved under this law since 1996, although afamelanotide is the first to be approved while under clinical investigation.

“Five years ago, Clinuvel made a decision to develop afamelanotide specifically for patient populations who were most severely and acutely affected by UV and light,” said Dr Philippe Wolgen, Clinuvel’s CEO.

“Today’s news comes as a welcome surprise but supports our choice to develop afamelanotide in these categories of patients.”

According to Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg, this suggests physicians and patients are becoming more empowered in influencing drug development.

“We have seen a world-first in UV treatment: patients and physicians requesting regulators to allow access to the novel drug," he said.