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Stabilizing PNH

The US Food and Drug Administration (FDA) recently granted orphan drug designation to Alexion Pharmaceuticals, Inc’s eculizumab (Soliris) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The therapy slows the destruction of abnormal PNH red blood cells by endogenous proteins. Approval was based on a randomized, double-blind, placebo-controlled clinical trial involving 87 PNH patients, 50% of patients treated with eculizumab experienced blood hemoglobin level stabilization versus no stabilization with placebo.

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Controlling Glucose

Merck & Co, Inc's combination sitagliptin/metformin oral tablet (Janumet) has recently received FDA approval for the treatment of type 2 diabetes mellitus. While the metformin component lowers glucose levels, the sitagliptin causes significantly lower hemoglobin A1C (HbA1c) levels. Results from a study of 701 patients with elevated HbA1c levels showed that patients receiving the drug experienced a 0.7% greater reduction in HbA1c levels than those receiving metformin alone, and half of the combination therapy recipients attained HbA1c levels < 7%.

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Halting Reinfection

Already FDA-approved for the prevention of hepatitis B infection due to hepatitis B surface antigen (HBsAg)-positive blood exposure from sexual contact or perinatal transmission, Cangene Corporation’s intravenous human hepatitis B immune globulin (HepaGam B) recently received approval for the prevention of hepatitis B reinfection in liver-transplant patients. Results from clinical trials showed that the treatment reduced the rate of viral reinfection from approximately 86% to 13%. The drug is available in 1 mL and 5 mL dosages.

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Fighting Skin Infection

GlaxoSmithKline, Inc, recently received FDA approval for their topical antibacterial, retapamulin ointment 1% (Altabax), for the treatment of impetigo. The twice-daily ointment is administered over 5 days and stops protein synthesis by binding to the bacterial ribosomes’ 50S subunit. Approval followed the results of a phase 3 clinical trial, in which 85.6% of patients using retapamulin needed no further antibacterial treatment after the 5 day trial, versus 52.1% receiving placebo.

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