Medexus Pharmaceuticals Inc (CVE:MDP) (OTCMKTS:PDDPF) is on the receiving end of good news as Health Canada has awarded the specialty pharmaceutical company priority review status for its drug Gliolan, which aids the extraction of malignant brain tumors during surgery.
Medexus has the exclusive rights to market and distribute the drug in Canada, which helps neurosurgeons have a better chance at removing malignant brain tumors (gliomas) completely as they become fluorescent and glow during surgery, thanks to its influence.
Medexus expects to file a new drug submission for Gliolan this year to market and sell the drug in Canada.
READ: Medexus Pharmaceuticals receives boost for its Gliolan drug as Health Quality Ontario recommends public funding
Winning priority review status from Health Canada shortens the review period for Gliolan to 180 days from 300 days. The privilege is granted when a drug treats serious or life-threatening diseases for which treatments are not readily available in Canada.
“Priority review for Gliolan should significantly accelerate our path to approval and follows the recent draft recommendation for public reimbursement by Health Quality Ontario,” said Ken d’Entremont, CEO of Medexus in a statement. “Once Gliolan becomes a fully registered product, we expect it to gain much broader distribution in Canada, which represents a sizeable, underserved market opportunity.”
Gliolan aids in the removal of high-grade cancerous gliomas in the brain. Its introduction in Canada, if approved, would see considerable demand as there are no rival drugs yet approved in Canada that help to visualize malignant tissue during glioma surgery.
Health Canada has already granted Medexus the right to distribute Gliolan in Canada under the Special Access program, which offers doctors access to non-marketed drugs to treat patients with serious or life-threatening conditions which cannot be addressed with conventional therapies.
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