GlaxoSmithKline's idiopathic thrombocytopenic purpura therapy Promacta will undergo a review by FDA's Oncologic Drugs Advisory Committee May 30.

GSK is seeking approval for short-term, second-line use of eltrombopag to increase platelet counts and reduce or prevent bleeding in patients with chronic ITP. The company plans to follow up with a broader application for chronic ITP this year (¹ Also see "GSK Files Promacta NDA For Short-Term Treatment Of ITP" - Pink Sheet, 20 December, 2007.).

Separately, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee will evaluate Amgen's application to extend psoriasis therapy Enbrel (etanercept) to the pediatric population June 18.

Amgen is proposing the tumor necrosis factor inhibitor, which recently added a "black box" warning on risk of infection to labeling, be approved for second-line treatment of moderate to severe psoriasis.

Johnson & Johnson's carbapenem antibiotic doripenem will be evaluated by the Anti-Infective Drugs Advisory Committee July 16 for the treatment of nosocomial pneumonia, including ventilator-assisted pneumonia.

Doribax was approved in October for intra-abdominal and urinary tract infection (² Also see "Ortho-McNeil Gets FDA Approval For Complicated Intra-Abdominal/UTI Therapy Doribax" - Pink Sheet, 15 October, 2007.).

-Brian Marson (b.marson@elsevier.com)

Promacta, Doribax Applications Get Advisory Committee Reviews

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