FDA Actions in Brief April 2011 (Benlysta, Yervoy, Zostavax, Banzel Oral Suspension, Intuniv, Promacta, Gadavist)

April 1, 2011

Recent FDA Approvals (through March 2011) related to Benlysta, Yervoy, Zostavax, Banzel Oral Suspension, Intuniv, Promacta, Gadavist

Belimumab (Benlysta, Human Genome Sciences and GlaxoSmithKline) was approved to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. It is the first inhibitor designed to target B-lymphocyte stimulator protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

Ipilimumab (Yervoy, Bristol-Myers Squibb) was approved to treat patients with late-stage (metastatic) melanoma.

An expanded age indication for Zoster Vaccine Live (Zostavax, Merck) was approved for the prevention of herpes zoster in adults aged 50 to 59 years.

Guanfacine (Intuniv, Shire) once-daily extended-release tablets were approved as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder in children and adolescents aged 6 to 17 years as part of a total treatment program.

Eltrombopag (Promacta, GlaxoSmithKline) oral tablet was approved for the treatment in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to cortiocosteriods, immunoglobulins, or splenectomy.

Gadobutrol (Gadavist, Bayer Pharmaceuticals), a gadolinium-based agent, was approved for use in patients undergoing magnetic resonance imaging of the central nervous system.