FDA Pipeline preview, January 2009 (ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, ecallantide)

Recent FDA action (through January 2009) related to ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, and ecallantide

Complete response

• Ceftobiprole (Johnson & Johnson) for the treatment of complicated skin and skin-structure infections, including diabetic foot infections

•Oblimersen (Genasense, Genta) in combination with chemotherapy for the treatment of chronic lymphocytic leukemia

•Rufinamide (Banzel, Eisai) as adjunctive treatment for partial-onset seizures with and without secondary generalization in patients aged ≥12 years

Recommendations for approval

•Febuxostat (Takeda) for the treatment of hyperuricemia in patients with gout

•Telavancin (Theravance) for the treatment of complicated skin and skin-structure infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA)

Priority review

•Ecallantide (Dyax) for the treatment of acute attacks of hereditary angioedema (HAE)