FDA approves Concordia’s Photofrin 630 laser

Concordia International (NSDQ:CXRX) said it won pre-market approval from the FDA for its Photofrin 630 laser, which is designed to activate an anti-cancer drug in patients with throat and lung cancers.

Oakville, Ontario-based Concordia said the device is designed to activate the drug Photofrin (porfimer sodium) in patients with esophageal cancer, Barrett’s Esophagus and non-small cell lung cancer. The Photofrin 630 laser was re-engineered to include new controls and peripheral systems, the company said.

“We anticipate that these improvements could support greater adoption of PDT with Photofrin within the oncology community,” chairman & CEO Mark Thompson said in prepared remarks. “In addition, PMA approval for this new laser represents an important milestone in our global growth plans for this asset.”

Concordia said it’s also running a Phase III trial of Photofrin in treating a bile duct cancer called cholangiocarcinoma.

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