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Janssen speeds up guselkumab approval process

New HQ of Morphosys, which developed guselkumab, © MorphoSys AG


by tg

Janssen speeds up US approval of psoriasis antibody guselkumab and targets further indications.

Janssen Research & Development, LLC has accelerated the US market approval process of guselkumab, a human anti-IL-23 antibody licenced from MorphoSys AG, in moderate to severe plaque psoriasis. According to its partner, the Johnson & Johnson affiliate applied a priority review voucher to the guselkumab biologics license application (BLA). In case of a positive decision by the FDA, Janssen expects US approval in Q3/17.

Janssen said it will conduct  three new phase III trials with the anti-inflammatory antibody: a head-to-head efficacy study of guselkumab vs. Novartis’ anti-IL 17A antibody secukinumab (ECLIPSE study) currently enrolling patients in the indication targeted for approval; a study in psoriatic arthritis set to start in Q3/17; and a Phase III programme in Crohn's disease.

Psoriasis is a bull market with 125 million patients worldwide, 20% of which are estimated to have the moderate to severe form.




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