Two new substitutes for fat will soon be available in supermarkets in the USA, not directly, but incorporated into low-fat foods. Simplesse (NutraSweet) has already been approved for use by the US Food and Drug Administration (FDA) and is commercially available in some areas, but only in an ice-cream-like product called Simple Pleasures. Trailblazer (Kraft General Foods) is expected to be approved soon.

Breathe Right, an adhesive bandage device that pulls open the nostrils, has been approved by the US Food and Drug Administration and is being heavily promoted to the general public as a treatment for snoring and night-time nasal congestion. The manufacturer's suggested retail price is $4.99 for a box of 10 strips.

The FDA has approved peginterferon alfa-2b (Sylatron – Merck) for adjuvant treatment of node-positive melanoma after surgical resection. Pegylated interferon has a longer duration of action than interferon alfa-2b (Intron A), which is also FDA-approved for adjuvant treatment of malignant melanoma after surgery, and can be given once a week, compared to 3-5 times a week for standard interferon.

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Harvoni, a once-daily fixed-dose combination of the direct-acting antiviral agents ledipasvir and sofosbuvir approved by the FDA in 2014 for treatment of hepatitis C virus (HCV) genotype 1 infection,1 has now been approved for use in patients infected with HCV genotype 4, 5, or 6, and in patients co-infected with HCV and HIV-1. A 12-week course of treatment with Harvoni plus ribavirin has also been approved as an alternative to 24 weeks of Harvoni alone for treatment-experienced, cirrhotic patients with HCV genotype 1 infection.HCV genotypes 4, 5, and 6 are responsible for <2% of HCV cases...

The FDA has approved Admelog (Sanofi-Aventis), an insulin lispro product similar to Humalog (Lilly), which went off patent in 2013.Approval of Admelog was based on efficacy data with Humalog and on two 6-month, open-label, randomized, noninferiority trials. In SORELLA 11 in 507 patients with type 1 diabetes and SORELLA 22 in 505 patients with type 2 diabetes, Admelog was noninferior to Humalog in lowering A1C, fasting plasma glucose levels, and self-monitored plasma glucose levels. The incidence of adverse effects, including hypoglycemia, was similar.Even though Admelog is very similar to...

The adeno-associated virus (AAV) vector-based gene therapy delandistrogene moxeparvovec-rokl (Elevidys – Sarepta) received accelerated approval from the FDA in 2023 for treatment of ambulatory children 4-5 years old with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene. It has now received full approval for use in ambulatory patients ≥4 years old and accelerated approval for use in nonambulatory patients with DMD.

The amyloid beta-directed monoclonal antibody lecanemab-irmb (Leqembi – Eisai/Biogen) has now been approved by the FDA for once-monthly use for treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia. It was previously approved only for administration once every 2 weeks. Now, lecanemab can be given every 4 weeks after an 18-month initiation phase of biweekly administration.

Antimicrobial prophylaxis can decrease the incidence of postoperative surgical site infection after some procedures. Since the last Medical Letter article on this subject, consensus guidelines have been published. Recommendations for prophylaxis in specific surgical procedures are listed in Table 1.

Full-page advertisements in newspapers are urging patients with type 2 diabetes coming off Rezulin to ask their doctors to switch to Avandia or Actos. Troglitazone was withdrawn from the market on March 21 because of rare but severe hepatic toxicity.