October 16, 2020 -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval for the expanded use of guselkumab (Tremfya), a monoclonal antibody (mAb) from the Janssen Pharmaceutical Companies of Johnson & Johnson.
The approval means the drug could be used for the treatment of adult patients with active psoriatic arthritis and applies only to the European Union (EU). Currently, guselkumab is approved in the EU to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Guselkumab selectively binds to the p19 subunit of interleukin 23 (IL-23 ) and inhibits its interaction with the IL-23 receptor, which contributes to the pathogenesis of inflammatory diseases such as psoriatic arthritis.
CHMP's recommendation is based on data from the phase III clinical trials Discover-1 and Discover-2 that demonstrated the efficacy and safety of guselkumab at 100 mg q4w and q8w for psoriatic arthritis patients.
Guselkumab is currently approved in the U.S., Canada, Japan, Brazil, and Ecuador for the treatment of adults with active psoriatic arthritis. The European Commission is expected to make a final decision regarding the drug's expansion later this year, Janssen said.