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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 1 | Issue 14
August 15, 2019

Chief Author: Kevin Lavery, PharmD
Editor: Dana Ranallo, PharmD

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Clinical Update

Few supplements show added benefit to cardiovascular health

According to a research review published in Annals of Internal Medicine, few nutritional supplements have been shown in clinical trials to provide protective effects against cardiovascular disease and related death, and some may even be harmful. In compiling their analysis, a team of researchers examined data from 277 trials, made up of nearly one million participants, to evaluate the impact of 16 different supplements and eight dietary regimens on the risk of cardiovascular disease and stroke. The analysis concluded that reduced salt intake and use of omega-3 fatty acids and folic acid could be beneficial, while the concurrent use of calcium with vitamin D supplements might increase the risk of stroke. Researchers emphasized that current U.S. dietary guidelines do not recommend routine supplement use to reduce the risk for cardiovascular disease, while noting that despite the lack of evidence confirming a definitive benefit for most supplements, roughly half of U.S. adults take some form of supplementation.

Safety First

New analysis of pregnancy rates and associated adverse events related to maternal isotretinoin use

In a new study published in Jama Dermatology, researchers conducted an analysis of reports contained in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to determine the rate of pregnancy and pregnancy-related adverse events among women taking isotretinoin. Isotretinoin is a commonly used acne treatment that carries a boxed warning for severe birth defects if taken by women who are pregnant or who become pregnant. The researchers identified 6,740 reported pregnancies among women taking isotretinoin between 1997 and 2017. During that time frame, the peak in annual pregnancies occurred in 2006, with 768 pregnancies reported. The year 2006 also coincided with the initiation of the iPLEDGE Program, which was intended to reduce fetal exposure to isotretinoin through patient and provider education and intervention. Although the analysis showed a downward trend in reported pregnancies, abortions, and fetal defects following the implementation of iPLEDGE, researchers report that all three events remain a persistent issue, with between 218 and 310 pregnancies being reported each year since 2011.

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From the Industry

NIH and partners to launch an HIV vaccine efficacy trial

In a news release published on July 15, 2019, the National Institutes of Health (NIH) announced plans to conduct a phase III trial of an investigational HIV vaccine regimen in the Americas and Europe. The trial, referred to as Mosaico, will assess whether an investigational HIV vaccine has the ability to prevent the acquisition of HIV among men who have sex with men (MSM) and transgender people. Mosaico will study outcomes of 3,800 HIV-negative men and transgender people between the ages of 18 and 60 years old, who have sex with men and/or transgender people. All participants will have access to comprehensive HIV prevention, including pre-exposure prophylaxis (PrEP), and will be randomly assigned to receive the investigational vaccine or placebo. Mosaico will be the third HIV vaccine efficacy trial in progress worldwide.

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FDA Approvals

Recent FDA Approvals

New Combination: Recarbrio™ (imipenem/cilastatin/relebactam)
Intravenous infusion for the treatment of complicated urinary and intra-abdominal infections in adult patients [7/16/2019 – Priority Review – MERCK SHARP DOHME]

New Biosimilar: Hadlima™ adalimumab-bwwd) Reference Product: Humira® (adalimumab)
Subcutaneous injection for the treatment of numerous autoimmune conditions [7/23/2019 – SAMSUNG BIOEPIS CO LTD]

Novel Drug Approval: Accrufer® (ferric maltol)
Oral capsule for the treatment of iron deficiency in adult patients [7/25/2019 – SHIELD TX UK LTD]

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New Generics

New Generics Entering the Marketplace

Lyrica® (pregabalin)
Indication: Neuropathic pain
Dosage Form/Strength: 25MG, 50MG, 75MG, 100MG, 150MG, 200MG, 225MG, 300MG Capsules; 20MG/ML Solution
Average Wholesale Price (AWP): Generic = Capsules ($534 - $801); Solution ($1,908) | Brand = Capsules ($562-$1,172); Solution ($2,245)

Rozerem® (ramelteon)
Indication: Insomnia
Dosage Form/Strength: 8MG Tablets
Average Wholesale Price (AWP): Generic = 8MG ($444) | Brand = 8MG ($467)