Posted 9 October 2019
The FDA has approved a drug developed by a Melbourne company used to treat patients with extreme reactions to light.
Local company Clinuvel announced the approval this week after it won priority review for Scenesse from the US regulator in January. The drug is already approved in Europe.
Scenesse is indicated for erythropoetic protoporphyria (EPP), a condition that can cause burns or ulcers on the skin of patients when they are exposed to light, especially sunlight.
This can lead patients to live a life indoors or during nocturnal hours, the company said.
"This is one day on which all interests converge and history is written both for the US EPP patient community and investors who have actively supported our mission for the last 14 years," Clinuvel's CEO Dr Phillippe Wolfen said.
"The FDA approval of Scenesse as a new molecular entity and medical innovation is memorable for this company and for the Australian life science sector.
"This event is transformational in that we are now accelerating our exchange with the FDA and EMA to expand the use of Scenesse in additional indications."
The approval was based on three phase 3 trials that showed the drug helped reduce the number and severity of phototoxic reactions compared to placebo, as well as real world evidence from the European launch of the drug.