Clinuvel secures Canadian approval for 16mg drug

• Health Canada has granted a notice of compliance to Clinuvel for its drug SCENESSE.
• The approval allows the company to commercially expand its regulatory footprint into the Canadian market.
• The company aims to provide the peptide therapy to patients suffering from erythropoietic protoporphyria.

Clinuvel (ASX:CUV) has secured a notice of compliance from Health Canada to market its 16mg SCENESSE drug for adult patients with erythropoietic protoporphyria, expanding its regulatory footprint into North America.

The clearance follows previous international marketing authorisations granted to the company in Europe in 2014, the United States in 2019, and Australia in 2020.

“Health Canada has taken a long time to arrive at this positive outcome,” said Clinuvel Chief Scientific Officer Dr Dennis Wright.

The company stated that the network expansion will target a rare metabolic disorder affecting 5,000 to 10,000 individuals globally, including 1 in 140,000 people in Canada.

Following the announcement, the Clinuvel share price was unchanged at $10.27.

Training and accreditation have already been completed for five specialty centres across Canada to distribute the peptide therapy under special access arrangements.

Globally, over 21,000 doses of the treatment have been administered to patients under expert care.