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2 Information about voclosporin

Anticipated marketing authorisation indication

2.1 Voclosporin (Lupkynis, Otsuka) is anticipated to be indicated 'in combination with mycophenolate mofetil for the treatment of adult patients with active class 3, 4 or 5 (including mixed class 3/5 and 4/5) lupus nephritis'.

Dosage in the marketing authorisation

2.2 The dosage schedule will be available in the summary of product characteristics for voclosporin.

Price

2.3 The proposed list price for voclosporin is commercial in confidence. The list price of mycophenolate mofetil (MMF) is £6.83 per 50‑pack of 500‑mg tablets (excluding VAT; drugs and pharmaceutical electronic market information tool, accessed October 2022).

2.4 The company has a commercial arrangement, which would have applied if voclosporin had been recommended.