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Home Industry News Janssen receives CHMP backing for EU approval of psoriasis therapy

Janssen receives CHMP backing for EU approval of psoriasis therapy

19th September 2017

Janssen has announced that its new therapy guselkumab has been recommended for EU approval as a treatment for adults with plaque psoriasis.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorisation of guselkumab in the treatment of moderate to severe plaque psoriasis patients who are candidates for systemic therapy.

This filing was based on positive findings from three phase III clinical trials, which have demonstrated the strong safety and efficacy performance of this innovative new therapy.

Following this positive opinion, a final decision from the European Commission is expected later this year. If approval is granted, Janssen plans to market guselkumab under the brand name Tremfya.

Jose Antonio Buron Vidal, Janssen's vice-president for medical affairs in Europe, the Middle East and Africa, said: "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."

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