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TREMFYA (Janssen-Cilag Pty Ltd)
Product name
TREMFYA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
191 (255 working days)
Active ingredients
guselkumab
Registration type
EOI
Indication
Plaque psoriasis
TREMFYA is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Psoriatic arthritis
TREMFYA is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior DMARD therapy.
Ulcerative colitis
TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.
Crohn’s disease
TREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.