FDA actions in brief

June 1, 2013

 

Radium Ra 223 dichloride (Xofigo, Bayer) was approved to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

Label changes incorporating lower dosages for sleep medications containing zolpidem (Ambien and Ambien CR, Sanofi and Edluar, Meda AB) were approved. The agency said patients who take zolpidem extended-release drugs should not drive or take part in activities that require complete mental alertness the next day.

Fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance) was approved for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. 

Canakinumab (Ilaris, Novartis) was approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection.

EGFR Mutation Test (Genentech, a member of the Roche Group and OSI Pharmaceuticals), a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of non-small cell lung cancers.

A new indication for golimumab (Simponi, Janssen) injection was approved to treat adults with moderate to severe ulcerative colitis.

Nimodipine oral solution (Nymalize, Arbor) was approved to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage).

Ezetimibe and atorvastatin (Liptruzet, Merck) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

Efavirenz (Sustiva, Bristol-Myers Squibb) Supplemental New Drug Application was approved for HIV-1 in pediatric patients as young as 3 months and weighing at least 7.7 pounds. The approval includes a "capsule sprinkle" administration option for those who can't swallow capsules or tablets, whereby capsules are broken open and the contents are sprinkled on food or a beverage. 

Cysteamine bitartrate (Procysbi, Raptor Pharmaceuticals) delayed release capsules for the treatment of nephropathic cystinosis in adults and children aged 6 years and older. Sustaining appropriate levels of cysteamine in the body is the key to maintaining organ function and lowering the likelihood of kidney transplantation.