Janssen Cilag to withdraw Invokana from German market

Janssen Cilag GmbH has announced the withdrawal of Invokana® (canagliflozin), a treatment for type 2 diabetes, from the German market. The decision follows a negative ruling from Germany's Federal Joint Committee (G-BA) regarding an early benefit assessment.

The G-BA did not recognize the study data submitted for the assessment, and consequently, no additional benefit was granted to the canagliflozin therapy option. As a result, Janssen Cilag GmbH will not enter into price negotiations with the Association of Statutory Health Insurance Funds (GKV-Spitzenverband). This necessitates the immediate discontinuation of Invokana® (canagliflozin) 100 mg and 300 mg, in all package sizes, within Germany.

Effective October 15, 2014, the medication will no longer be prescribable or reimbursable. Patients currently being treated with Invokana are advised to consult their treating physician to arrange for an individual therapy adjustment. The company stated that concerns regarding the efficacy, safety, or quality of the medication do not exist.

Janssen Cilag GmbH has initiated a process to recall all existing stock from wholesalers and pharmacies. Pharmacies holding the medication are instructed to contact Janssen Customer Service for return processing instructions.