Regulatory Decision Summary for Copaxone

This Supplement to a New Drug Submission was submitted to gain approval for the addition of an alternative presentation for Copaxone (glatiramer acetate injection). Copaxone is an immunomodulator indicated for the treatment of relapsing forms of multiple sclerosis.

It is currently available as a prefilled syringe (PFS) solution for subcutaneous injection (20, 40 mg/mL). With this submission, the Sponsor proposed the addition of a 40 mg/mL pre-filled pen. The pen is filled by loading the pre-filled syringe into a D1-type autoinjector (as defined by ISO 11608-1) to form an integrated “injection pen.”

The Sponsor demonstrated that the proposed pre-filled pen has been designed and manufactured to ensure consistent product performance identical to that of the current approved pre-filled syringe as well as in accordance with ISO requirements for medical devices which are relevant to product performance including: deliverable volume, dosing accuracy, device integrity and robustness and biocompatibility.

The Benefit-Harm-Uncertainty profile remains positive when Copaxone is used according to the Product Monograph.

For further details about Copaxone, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.