Regulatory Decision Summary for Spevigo (spesolimab)

The present application provides data to support a new spesolimab 2 mL pre-filled syringe (PFS) (150 mg/mL formulation) with a needle safety device. Spevigo already has a 1 mL pre-filled syringe (PFS) of the same formulation approved. The recommended 300 mg dose remains unchanged, as the dose was previously approved as two 150 mg injections. The introduction of the larger volume syringe will reduce the number of injections per dosing.

The sponsor has submitted sufficient evidence that the new presentation, a 2 mL pre-filled syringe (PFS) of 150 mg/mL has comparable pharmacokinetic (PK) properties as the already approved 2 x 1 mL pre-filled syringe (PFS) of 150 mg/mL. A study was conducted in healthy subjects at the recommended dose of 300 mg and a second study was conducted at supratherapeutic dose in patients with Plantar pustulosis, a condition similar but less severe than Generalized Pustular Psoriasis (GPP). Both studies showed that the new presentation of a 2 mL pre-filled syringe (PFS) had comparable PK profile and bioavailability and that, therefore, no clinical difference was expected between the two presentations.

There is sufficient evidence to conclude that the benefit-risk profile for the Spevigo PFS (pre-filled syringe) -NSD (needle safety device) -2 (2 mL pre-filled syringe) is favourable.

The evaluation of the chemistry, manufacturing, and control data confirms that the methods and processes for the production, release, and stability testing of Spevigo 300 mg PFS with needle safety device are well-established and controlled, thus ensuring the consistent manufacture of a safe, pure, and potent product. 

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