Ustekinumab pipeline update August 2008

[diana.papshev]

Ustekinumab by Centocor, FDA advisory committee unanimously recommended approval in 6/08
• Class/MOA: human monoclonal antibody
• Use: treatment of adult patients with chronic moderate to severe plaque psoriasis
• Dosage form: SC injection
• Link to press release:

o News article 6/08
o Centocor Press Release 6/08

• Link to clinicaltrials.gov:

o Phase III safety and efficacy study in Patients With Severe Plaque-Type Psoriasis
o Phase III safety and efficacy study compared to Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis

• Link to published data:

o PHOENIX 1 study [Lancet. 2008] – PubMed Results
o PHOENIX 2 study [Lancet. 2008] – PubMed Results

Update: The FDA review timeline has been extended to December 2008, to accommodate for review of amendments recently submitted by Centocor