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FDA Pipeline preview, November 2008 (aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, artemether/lumefantrine)
Recent FDA action (through November 2008) related to aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, and artemether/lumefantrine
Complete responses
• Aztreonam lysine for inhalation (Gilead) for the treatment of Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF)
• Fentanyl buccal tablet (Fentora, Cephalon) for the treatment of noncancer breakthrough pain in opioid-tolerant patients
• Tocilizumab (Actemra, Roche) for the treatment of moderate-to-severe rheumatoid arthritis (RA)
Priority review
• Recombinant form of human antithrombin (ATryn, GTC) for the prophylactic treatment of deep vein thrombosis (DVT) and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high-risk surgical or childbirth procedures
• Artemether/lumefantrine (Coartem, Novartis) for the treatment of malaria
• Everolimus (Novartis) for the treatment of advanced kidney cancer after failure of standard treatment
Orphan drug designation
• ENB-0040 (Enobia) for the treatment of hypophosphatasia
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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