FDA pipeline preview, November 2007

The latest FDA action (through November 2007) related to anecortave depot suspension (Retaane), lamotrigine extended-release (Lamictal XR), pramlintide injection (Symlin), frovatriptan (Frova), lumiracoxib (Prexige), PI-88, C1 inhibitor (Cinryze), Etravirine, IPI-504, Parathyroid hormone (rDNA origin) for injection (Preos), and pafuramidine

Key Points

Approvable designations

• Anecortave depot suspension (Retaane, Alcon) for the treatment of wet age-related macular degeneration

• Lamotrigine extended-release (Lamictal XR, GlaxoSmithKline) for the treatment of epilepsy

• Pramlintide injection (Symlin, Amylin) for use with basal insulin (without mealtime insulin) in patients with type 2 diabetes who have not achieved desired glucose control

• Frovatriptan (Frova, Endo/Vernalis) for the short-term prevention of menstrual migraine

• Lumiracoxib (Prexige, Novartis) for the once-daily treatment of osteoarthritic pain

Fast-track designation

• PI-88 (Progen) for the prevention of tumor recurrence following curative liver resection in patients with hepatocellular carcinoma

Priority review

• C1 inhibitor (Cinryze, Lev) for the acute treatment of hereditary angioedema

• Etravirine (TMC125, Tibotec) in combination with other antiretroviral agents for the treatment of HIV-1 in adult treatment-experienced patients

Orphan drug designations

• IPI-504 (Infinity/MedImmune) for the treatment of gastrointestinal stromal tumors

• Parathyroid hormone (rDNA origin) for injection (Preos, NPS) for the treatment of hypoparathyroidism

• Pafuramidine (DB289, Immtech) for the treatment of human African trypanosomiasis (African sleeping sickness)