FDA's pushback to December of the PDUFA date for the psoriasis drug ustekinumab gives the agency time to review amendments made by Centocor.

The Horsham, Pa.-based firm said Aug. 8 that FDA needs more time to look at the BLA for subcutaneously injected ustekinumab, which targets the p40 subunit of interleukins 12 and 23, but the Johnson & Johnson unit added that regulators are not asking for more trials.

An advisory panel in June gave a unanimous thumbs-up to the compound for adult moderate to severe psoriasis but asked for long-term studies to evaluate cancer risk due to the drug's mechanism of action (¹ Also see "FDA Panel Unanimously Recommends Centocor’s Ustekinumab" - Pink Sheet, 17 June, 2008.).

The same panel on the same day gave its blessing to Amgen's Enbrel (etanercept) for pediatric psoriasis. It's already approved for adults and used off-label in children.

Leerink Swann analyst William Tanner, in a July 29 research note on Amgen's second-quarter earnings, wrote that Enbrel "continues to eke out some growth," but expressed concern about the firm's reliance on the dermatology market - especially with ustekinumab in the wings.

Enbrel also is approved for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis.

FDA's delay of ustekinumab gives Enbrel breathing room while Amgen develops its bone drug denosumab. In June, Thousand Oaks, Calif.-based Amgen reported positive Phase III results with denosumab in postmenopausal osteoporosis (² Also see "Amgen’s Positive Denosumab Pivotal Trial Reduces Overhangs For Firm" - Pink Sheet, 29 July, 2008.).

The monoclonal antibody denosumab targets the RANK ligand, and analysts have predicted it could sell $2.4 billion worldwide by 2016.

- Randall Osborne (r.osborne@elsevier.com)

FDA Holds Up Centocor’s Ustekinumab Three Months But Wants No New Trials

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