Global healthcare giant Johnson & Johnson (J&J; NYSE: JNJ) has announced the submission of two supplementary Biologic License Applications (sBLAs) to the US Food and Drug Administration (FDA) for its drug Tremfya (guselkumab). The applications seek to expand the indications for children aged 6 years and older with moderate-to-severe plaque psoriasis (PsO) and children aged 5 years and older with active juvenile psoriatic arthritis (jPsA).
Tremfya’s Existing Approvals and New Indications
Tremfya, an interleukin-23 (IL-23) inhibitor, is already approved in the US for the treatment of adult moderate to severe plaque psoriasis, adult active psoriatic arthritis, and adult moderate to severe active ulcerative colitis. The new filings aim to extend the benefits of this therapy to younger patient populations.
Clinical Data Supporting the Applications
For the plaque psoriasis indication in children, the filing is supported by results from the Phase III PROTOSTAR study and bridging data from Phase III VOYAGE 1 and 2 studies. In the case of juvenile psoriatic arthritis, the application is based on pharmacokinetic (PK) extrapolation analyses from adult PsA studies (DISCOVER 1 and 2) and Tremfya’s efficacy and safety data from the PROTOSTAR study.-Fineline Info & Tech
