Janssen-Cilag International’s biologic drug guselkumab (Tremfya) has received approval from the European Commission (EC) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Janssen-Cilag International’s innovator biologic drug guselkumab (Tremfya) has received approval from the European Commission (EC) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Tremfya is the first European Commission-approved biologic that selectively blocks interleukin-23 (IL-23), a cytokine that is a key driver of the immune inflammatory response in psoriasis. The drug is also the only FDA-approved selective IL-23 blocker for the treatment of plaque psoriasis.
Tremfya is a self-injectable treatment that requires 2 starter doses, 1 initially and another 4 weeks later, followed by a maintenance dose every 8 weeks thereafter. Tremfya’s good safety profile, superior head-to-head results compared with Humira (adalimumab) in the VOYAGE 1 and 2 trials, and its mode of action suggest that Tremfya could be a potential competitor to Humira.
The European Commission’s approval of Tremfya, like the earlier approval of the medication by the FDA, was based on data from 3 phase 3 clinical studies:
There were no clear signs of an increased risk of malignancy, major cardiovascular events, or serious infections in patients taking Tremfya.
In September, Janssen announced new, long-term data from the open-label extension of the VOYAGE 1 trial, which further solidified Tremfya’s efficacy:
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