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sBLA withdrawn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
Skyrizi Overtakes Humira in U.S. Sales Numbers
November 8th 2024For the first time, Skyrizi has replaced Humira as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
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FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
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