Once again, Johnson & Johnson is facing a delay before it gets a possible approval from regulators in the USA for its psiorasis drug Stelara.

The company’s Centocor Ortho Biotech unit has been told by the US Food and Drug Administration that the agency has extended by three months the review timeline for the Biologic License Application for Stelara (ustekinumab). The delay is due to the fact that an FDA advisory committee last June recommended that the drug be approved, but the agency then said in December that it required information on J&J’s risk evaluation and mitigation strategy to ensure that the benefits of ustekinumab outweigh the risks.

J&J says it responded to the FDA’s request in January but the agency says it needs another three months “to provide time for a full review of an amendment to the pending application”. The company noted that the amendment “pertains to testing results to establish the product's shelf life” and the FDA has requested no additional clinical trials for Stelara.

Jay Siegel, J&J's chief biotechnology officer, noted that "we remain focused on collaboration with the FDA and providing the necessary information to support the review and approval of Stelara for the treatment of adults with moderate to severe plaque psoriasis". The drug is the first in a new class of biologics which targets the cytokines interleukin-12 and -23, has already been approved by the European Commission and by regulators in Canada.

Current therapies available for the treatment of the disease include Wyeth's Enbrel (etanercept), which dominates the psoriasis market, Abbott Laboratories’ Humira (adalimumab) and J&J’s own Remicade (infliximab). J&J believes Stelara has an advantage over its rivals on the market of a more convenient dosing regimen, as patients need just five doses a year compared to as many as 104 injections with current biologic therapies.