Porphyria treatment now approved in Canada to prevent sun skin damage
Regulators OK Scenesse for adults with sunlight hypersensitivity due to EPP
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Scenesse (afamelanotide), an injection treatment that helps prevent sun-related skin damage in adults with erythropoietic protoporphyria (EPP) — a type of porphyria marked by skin hypersensitivity to sunlight — is now approved in Canada.
Health Canada cleared the therapy, given as a subcutaneous, or under-the-skin, injection, for use by EPP patients with so-called phototoxicity, marked by damage from even brief sunlight exposure, the therapy’s developer, Clinuvel, announced in a company press release.
The Canadian approval comes several years after similar authorizations in the U.S., the European Union, and Australia. According to Clinuvel, Scenesse is the only EPP treatment to receive formal marketing authorizations anywhere in the world. The company noted that five specialty centers in Canada have already been treating EPP patients with Scenesse under special access arrangements.
“Health Canada has taken a long time to arrive at this positive outcome,” said Dennis Wright, PhD, Clinuvel’s chief scientific officer. “I thank our team for this momentous outcome and their tenacity for ensuring eligible patients may get access to this therapy.”
EPP is a rare genetic disorder in which a molecule called protoporphyrin IX (PPIX) builds up to abnormal levels in the body’s tissues. When PPIX is exposed to sunlight, the molecule can be activated in a way that damages surrounding tissue.
For people with EPP, this means that any exposure to sunlight can lead to skin problems such as pain, redness, and thickening.
Scenesse has ‘proven’ safety, per developer
Scenesse is an implant inserted under the skin, given every two months, that helps reduce phototoxicity by prompting the body to produce more melanin, a pigment that normally helps shield the skin from sun-related damage. The therapy also acts as an antioxidant to reduce tissue damage.
Clinuvel sponsored two Phase 3 clinical trials that tested Scenesse against a placebo in dozens of adults with EPP. One of the trials was conducted in the U.S. (NCT01605136), while the other took place in Europe (NCT00979745).
Across both trials, the results showed that people with EPP treated with Scenesse were able to spend more time in the sun without pain than those given the placebo. The trial results also indicated that Scenesse treatment can improve quality of life for EPP patients, a finding mirrored in real-world studies.
According to its prescribing information in the U.S., the most common side effects of Scenesse include implant-site reactions, nausea, throat pain, cough, fatigue, dizziness, skin darkening, sleepiness, moles, respiratory tract infections, nonacute porphyria, and skin irritation.
Wright said the treatment’s mechanism of action is “well understood” and that the “major benefit of the drug is its proven long-term and consistent safety profile.”
“Data from our global programs — including considerable data from postmarketing experience — were used to demonstrate the safety and clinical benefit of Scenesse in EPP,” Wright said.
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