Marketing authorisation recommended for guselkumab in the EU
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the marketing authorisation in the EU for Janssen-Cilag International’s guselkumab — a treatment for moderate to severe plaque psoriasis.
If it receives approval, guselkumab will be the first biologic therapy that selectively targets interleukin (IL)-23, a key driver of the immune inflammatory response in psoriasis — a chronic disease for which there is currently no cure.
“People living with plaque psoriasis bear a tremendous physical and emotional burden due to the painful and visible nature of the disease, and there is a real need to improve upon current treatment options,” said José Antonio Burόn Vidal, vice president, Medical Affairs, Europe, Janssen Middle East and Africa (EMEA). “We are pleased guselkumab may soon be available to adults living with moderate to severe plaque psoriasis in Europe, because the evidence shows this novel therapeutic offers significant and lasting efficacy for patients in need of alternative treatment options.”
The EU filing has been submitted based on data from three Phase III clinical studies — VOYAGE 1 and 2 trials and the NAVIGATE trial.
Additionally, the company has recently presented longer-term data from VOYAGE 1, demonstrating consistent rates of skin clearance with guselkumab treatment at week 100. These results, presented at the 26th European Academy of Dermatology and Venereology (EADV) congress, reveal that more than 80% of patients treated with the therapy achieved at least a 90% improvement in psoriasis area severity index (PASI 90) or near complete skin clearance.
“These data show the rates of skin clearance with guselkumab were consistent at weeks 52 and 100 with every eight-week maintenance therapy. These important new findings contribute to the scientific evidence for targeting IL-23 in the treatment of moderate to severe plaque psoriasis,” said Professor Chris Griffiths, Foundation Professor of Dermatology at the University of Manchester, UK, VOYAGE 1 study steering committee member. “Also noteworthy is that skin clearance rates in patients transitioned to guselkumab from adalimumab improved and the rates were consistent at weeks 52 and100.”
A final decision on the approval of the biologic is anticipated from the European Commission (EC) later this year. The US Food and Drug Administration (FDA) approved guselkumab in July.