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sBLA withdrawn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
ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
December 19th 2024The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.
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