CHMP recommends approval for Janssen's mAb in psoriatic arthritis

By The Science Advisory Board staff writers

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.

NIH initiates ACTIV trial for COVID-19 immune modulators
The U.S. National Institutes of Health (NIH) has launched an adaptive phase III trial called Accelerating COVID-19 Therapeutic Interventions and Vaccines...
J&J to supply EU with 200M COVID-19 vaccine doses
Johnson & Johnson has received approval from the European Commission to supply 200 million doses of Janssen Pharmaceutical's COVID-19 vaccine...
BioSymetrics, Janssen, Sema4 use AI to predict COVID-19
BioSymetrics, Sema4, and Janssen Pharmaceuticals will use artificial intelligence (AI) to predict the onset and severity of COVID-19 among different populations.
J&J's Ebola vaccine approved by EU
Johnson & Johnson announced that the European Commission granted marketing authorization for its Janssen Pharmaceutical Ebola vaccine regimen for...
J&J announces manufacturing collaboration for COVID-19 vaccine
Johnson & Johnson, a Janssen Pharmaceuticals company, announced on April 24 a collaboration with Emergent BioSolutions to support the manufacturing...

Copyright © 2020

Building Biology in 3D Hybrid Symposium
October 26-27
La Jolla, California United States
Northeast Regional Laboratory Staff and Core Directors (NERLSCD) 2021
November 3-5
Portsmouth, New Hampshire United States
CPhI Worldwide 2021
November 9-11
Milan, Lombardia Italy
Society for Immunotherapy of Cancer (SITC) Annual Meeting
November 10-14
Washington, DC, District of Columbia United States
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter