Clinuvel Launches Light Intolerance Drug in the United States
April 16, 2020
Rare Daily Staff
Clinuvel, which won approval in October 2019 for Scenesse, its treatment for patients with a rare disorder in which exposure to light may be extremely painful, said it has launched the drug in the United States.
Erythropoietic protoporphyria is caused by mutations leading to impaired activity of ferrochelatase, an enzyme involved in heme production. Heme is an important component in hemoglobin, the oxygen carrying molecule in red blood cells. The decrease in ferrochelatase activity leads to an accumulation of protoporphyrin IX (PPIX) in the body. Light reaching the skin can react with PPIX causing intense skin pain and skin changes, such as redness and thickening.
Scenesse, a melanocortin-1 receptor agonist, increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light sources. It is an implant that is inserted under the skin. The FDA approved the drug to increase pain-free light exposure in adult patients with a history of damage to their skin from erythropoietic protoporphyria.
The company said more than 30 U.S. insurers nationwide have introduced coverage of Scenesse through Prior Authorization, acceptance as a specialty drug, or inclusion in their formulary.
“EPP is an insidious disorder which forces patients live in the darkness or risk second degree burns, known as phototoxicity, after only a few minutes of exposure to light or sun,” said Linda Teng, Clinuvel’s director of clinical affairs and compliance. “These patients have lived, lifelong, as social recluses, filled with anxiety towards any light sources.
More than 1,400 patients have received treatment with Scenesse in clinical trials, special, and compassionate access programs, and under a European marketing authorization.
Published peer-reviewed research has reported that the drug can reduce the frequency and severity of phototoxic reactions and, over time, enable patients to alter their lifelong behavior of avoiding outdoors and shunning social contacts, now able to lose their anxiety to light sources.
Scenesse is administered every two months by healthcare professionals in accredited specialty centers. A maximum of 30 specialty centers are being trained nationwide to provide long-term patient care and treatment monitoring.
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