First drug in new antiretroviral class blocks host-cell receptor in HIV
In two large phase 3 trials, maraviroc (Selzentry) significantly suppressed human immunodeficiency virus (HIV) and led to greater increases in CD4 cell counts. More than 1,000 adults with R5-tropic HIV and resistance to or previous treatment with drugs from three antiretroviral classes received either maraviroc or placebo. After 48 weeks, the maraviroc group had lower HIV RNA levels and greater CD4 increases than those on placebo. Drug toxicity was similar in both groups. Maraviroc blocks HIV from entering cells by binding to the CD4 molecule and the CCR5 coreceptor, a protein to which certain HIV subtypes attach. The first CCR5 antagonist to be approved, it is indicated only for patients with R5-tropic HIV.
FDA approves insulin glulisine for diabetic children
The Food and Drug Administration (FDA) has approved insulin glulisine (Apidra) to treat diabetes in children ages 4 and older, based on a review of a study in children with type 1 diabetes that compared the drug with insulin lispro. Given I.V. or with an infusion pump, a syringe, or an insulin pen, insulin glulisine acts rapidly and should be used in combination with a longer-acting insulin. When given by infusion pump, it shouldn’t be mixed with other insulins or liquids. It’s not intended for use during hypoglycemic episodes or by insulin-allergic patients.
New drug approved for overactive bladder
The FDA has approved Toviaz (fesoterodine fumarate) to treat adults with overactive bladder (OAB). An anticholinergic, it relaxes smooth muscle tissue of the bladder, easing urinary frequency, urgency, and incontinence. To be taken once daily, it will be available as an extended-release tablet in 4-mg and 8-mg dosage strengths. In two randomized controlled studies, the drug significantly decreased the number of times patients needed to urinate and the number of urine leakage episodes daily, compared to placebo. Common adverse effects include dry mouth and constipation.
Safety concerns trigger label update for psoriasis drug
Efalizumab (Raptiva) now comes with a boxed warning indicating the risk of life-threatening infections, including progressive multifocal leukoencephalopathy, viral meningitis, bacterial sepsis, and invasive fungal disease. The drug is a once-weekly injection for adults with moderate to severe plaque psoriasis who are candidates for whole-body therapy or phototherapy to control psoriasis. The FDA has received reports of serious infections leading to hospitalizations and several deaths in patients receiving it. The label update also will reflect the potential risk of permanent immunologic suppression in children.
Statins don’t increase ALS risk
A new FDA analysis shows that statins don’t increase the risk of developing amyotrophic lateral sclerosis (ALS). From 1991 to 2006, the agency received a higher-than-expected number of reports of ALS in patients taking statins. But when researchers analyzed data from 41 long-term controlled clinical trials, they found no increased ALS incidence in patients treated with a statin compared with placebo. The FDA is awaiting further data, but in the meantime it doesn’t advise changes in statin use or prescribing.
FDA approves Rapaflo for BPH symptoms
Rapaflo (silodosin) has been approved to treat symptoms of benign prostatic hyperplasia (BPH). A selective alpha-1 adrenergic receptor antagonist, it improves urine flow and decreases BPH symptoms by relaxing smooth muscles in the prostate, bladder, and urethra. The drug will be available in a once-daily capsule. A daily dosage of 8 mg is recommended for men without renal or hepatic impairment; a 4-mg daily dosage for those with moderate renal impairment. Rapaflo isn’t recommended for men with severe renal or hepatic impairment.