J&J submits BLA for guselkumab

Johnson & Johnson (NYSE:JNJ) said it submitted a BLA to FDA for guselkumab (CNTO 1959) to treat moderate to severe plaque psoriasis. The submission triggers an undisclosed milestone payment to MorphoSys AG (Xetra:MOR; Pink:MPSYY) from J&J.

The submission includes data from the Phase III VOYAGE 1 trial. Last month, J&J said the mAb targeting the p19 subunit of IL-23 showed superiority to both placebo and Humira adalimumab from AbbVie Inc. (NYSE:ABBV) in that trial. Reimbursement issues and other factors may limit guselkumab's use to patients who have failed prior therapies, however (see BioCentury, Oct. 10)...