Natalizumab, a recombinant humanized monoclonal antibody, has received accelerated approval from the FDA for intravenous treatment of relapsing forms of multiple sclerosis (MS). The beta interferons and glatiramer acetate are widely used for treatment of MS; they generally reduce the number of relapses by about 30% compared to placebo, and have been shown to be safe and effective for periods ranging from 4 to 10 years.

For patients with diabetes poorly controlled with a single oral drug, addition of a second drug with a different mechanism can be helpful. A fixed-dose combination (Actoplus met - Takeda) of two widely used antihyperglycemic drugs, the thiazolidinedione pioglitazone (Actos) and the biguanide metformin (Glucophage, and others), has been approved by the FDA for management of type 2 diabetes. It is indicated for patients already being treated with both pioglitazone and metformin or as second-line therapy for those not adequately controlled with either metformin or pioglitazone alone....

Posaconazole (Noxafil - Schering-Plough), an oral azole antifungal with a chemical structure similar to that of itraconazole (Sporanox), has been approved by the FDA to prevent Candida and Aspergillus infections in severely immunocompromised patients and for treatment of oropharyngeal candidiasis. It is likely also to be used off-label for treatment of other fungal infections, including those caused by Mucor and other Zygomycetes.

A variety of glucose monitoring devices have been used in an effort to reduce the hypoglycemia and wide glucose excursions that complicate insulin treatment of diabetes. Since the last Medical Letter issue reviewing such devices, more continuous glucose monitoring (CGM) systems have become available. Five devices available now, and two expected to be marketed soon, are listed in the table on page 14. The FDA has approved continuous glucose devices only for the observation of glucose trends.

Sitagliptin (Januvia) and metformin (Glucophage, and others) are now available in a single tablet (Janumet - Merck) for treatment of type 2 diabetes. The combination is approved by the FDA for use in patients not adequately controlled by sitagliptin or meformin alone or in those already taking both drugs. Metformin is also available in combination with the thiazolidinediones pioglitazone and rosiglitazone and with the sulfonylureas glipizide and glyburide.

Zoledronic acid (Reclast - Novartis) is the first bisphosphonate approved by the FDA for once-yearly intravenous (IV) treatment of osteoporosis in postmenopausal women. Reclast is also approved for treatment of Paget's disease. Another IV formulation of zoledronic acid (Zometa) is approved for treatment of hypercalcemia of malignancy, multiple myeloma and bone metastases from solid tumors.

Short-acting methylphenidate (MPH) is effective for treatment of attention-deficit/hyperactivity disorder (ADHD), but its 3-5 hour duration of action usually requires mid-day dosing in school, which children may find disruptive or stigmatizing.

A new fixed-dose tablet (PrandiMet - Novo Nordisk) combining metformin (Glucophage, and others) and repaglinide (Prandin) has been approved by the FDA for treatment of type 2 diabetes in patients already taking both metformin and repaglinide, or for patients not adequately controlled on either drug alone.

Three oral poly(ADP-ribose) polymerase (PARP) inhibitors have been approved by the FDA for treatment of advanced, recurrent ovarian cancer. Olaparib (Lynparza – AstraZeneca), niraparib (Zejula – Tesaro), and rucaparib (Rubraca – Clovis) are each approved for somewhat different indications and for patients with different biomarkers (see Table 2).