Italy jumps the gun and approves the melanocortin agonist peptide, Melanotan 1 (Afamelanotide). Melanotan peptide provides photo-protective benefit to skin condition suffers. afamelanotide, while it's still undergoing the regulatory process worldwide, has a cult following touting life-altering quality improvements.
Italy's National Health System has bucked the European regulatory system and approved the use of the photoprotective peptide-drug. Peptide injections of afamelanotide, prior or in addition to sunblock is likely to gain worldwide regulatory approval.
This means patients who suffer from the rare disorder, erythropoietic protoporphyria (EPP) - for which there is no current treatment besides minimizing exposure to sunlight - can be prescribed afamelanotide by Italian physicians, and the full cost will be reimbursed by the nat'l health system.
Biotech company has offered afamelanotide under compassionate use in the past to patients following the end of clinical trials in Australia/ United Kingdom.
"[b]Dr Philippe Wolgen, CEO wrote] Following the completion of the complex study of afamelanotide in Italian EPP patients, we continued to support their treatment through a compassionate use program"
"Unfortunately, the indefinite free supply of afamelanotide was not sustainable as a small enterprise, and this approval by the Italian regulators not only makes the melanocortins available to these trial patients, but also provides further incentive to the company to focus on orphan drug development.”
Italian legal restrictions contain provision to allow for the approval and reimbursement of peptides that treat conditions for which not alternative therapy exists, and when that medicine is still in clinical development.
36 drugs have already been approved under this law since 1996, although Melanotan 1 (afamelanotide) is the first to be approved while under clinical investigation.
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