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