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sBLA withdrawn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
FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers
September 13th 2024Tecentriq Hybreza can be administered over seven minutes, compared with 30 to 60 minutes for IV infusion of Tecentriq. There is no word yet on when Tecentriq Hybreza will be available or what the price will be.
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FDA Warns of Liver Injury with Veozah for Hot Flashes
September 12th 2024The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.
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