Concordia International Gets FDA Approval For New Photofrin Laser

Concordia International Corp. CXRX revealed that the Food and Drug Administration has approved its premarket approval application (PMA) for its new Photofrin 630 PDT Laser. According to the company, Photodynamic therapy (PDT) with Photofrin was its light-based cancer treatment integrating a photosensitizing drug called Photofrin (porfimer sodium) with a particular type of light administered by a laser to attack cancer cells.

Concordia said the newly approved laser has been re-engineered with technological advancements in laser design. The device is designed for use with Photofrin to treat esophageal cancer, Barrett's Esophagus and non-small cell lung cancer. The company added that these advancements included fresh controls and peripheral systems while maintaining the same specifications with minimal changes to the treatment procedures.

The company's chairman and CEO, Mark Thomson, said, "We anticipate that these improvements could support greater adoption of PDT with Photofrin® within the oncology community. In addition, PMA approval for this new laser represents an important milestone in our global growth plans for this asset."

Concordia also indicated it's assessing Photofrin as a rare disease product candidate through a final stage clinical study. The company added that its ongoing Phase 3 trial is assessing the product's safety, as well as efficacy as a potential treatment for cholangiocarcinoma, or bile duct cancer, which is a rare disease affecting about 2,000-3,000 patients annually in the United States.