NEWS - FDA extends review of psoriasis drug Stelara (ustekinumab)

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US FDA extends review of J & J psoriasis drug

Tue May 26, 2009 6:46pm EDT

LOS ANGELES, May 26 (Reuters) - U.S. regulators have extended for a

second time their review of & 's (JNJ.N) experimental

psoriasis drug, named Stelara, the company said on Tuesday.

J & J said the deadline for a decision by the Food and Drug

Administration was extended by three months and the agency has

requested no additional clinical trials.

An FDA advisory committee last June recommended that the drug, also

known as ustekinumab, be approved, but the agency said in December

that would hold off on making a decision on the marketing application

until it received certain risk-mitigation information.

J & J said it responded to that request in January.

" 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, "

Jay Siegel, J & J's chief biotechnology officer, said in a statement.

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Read the full article here:

http://www.reuters.com/article/governmentFilingsNews/idUSN2648887820090526

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