FDA Pipeline preview, March 2009 (cetuximab, prasugrel, risperidone, iclaprim, lasofoxifene, ecallantide, laquinimod, C1 inhibitor, SGN-35, omacetaxine)

Recent FDA action (through March 2009) related to cetuximab, prasugrel, risperidone, iclaprim, lasofoxifene, ecallantide, laquinimod, C1 inhibitor, SGN-35, and omacetaxine

sBLA withdrawn

• Cetuximab (Erbitux, Lilly/Bristol-Myers Squibb) for the treatment of advanced non-small cell lung cancer (NSCLC)

Complete response

• Iclaprim (Arpida) for the treatment of complicated skin and skin-structure infections

• Lasofoxifene (Pfizer) for the treatment of osteoporosis in postmenopausal women at increased risk of fracture

Recommended for approval

• Prasugrel (Daiichi Sankyo/Lilly) for the treatment of acute coronary syndromes (ACS) in patients managed with percutaneous coronary intervention (PCI)

• Ecallantide (DX-88, Dyax) for the treatment of acute attacks of hereditary angioedema (HAE)

Fast track designation

• Oral laquinimod (Teva/Active Biotech) for the treatment of relapsing-remitting multiple sclerosis (RRMS)

Priority review

• C1 inhibitor (human) (Cinryze, ViroPharma) for the treatment of acute attacks of HAE

Orphan drug designations

• SGN-35 (Seattle Genetics) for the treatment of anaplastic large cell lymphoma

• Omacetaxine (ChemGenex) for the treatment of myelodysplastic syndromes