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Pulse Newsletter

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

Volume 5 | Issue 21
December 1, 2023

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

Semaglutide Benefit in Secondary Prevention of Cardiovascular Events

On November 11, 2023, a new study analyzing the benefits of semaglutide was published in the New England Journal of Medicine. Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) available under the names Ozempic ® and Wegovy®. Ozempic® is prescribed in the treatment of diabetes, and Wegovy® is indicated for weight loss. The study enrolled over 17,000 patients ages 45 and older with pre-existing cardiovascular disease and a body-mass index (BMI) of 27 kg/m2 or greater, but with no history of a diabetes diagnosis. Cardiovascular disease was defined as previous stroke, previous heart attack or symptomatic peripheral arterial disease. The predominant qualifying cardiovascular event was a heart attack. Participants were split into a 1:1 ratio of receiving either a weekly injection of semaglutide 2.4mg or a placebo. Based on the results of the study, it was concluded that semaglutide was superior to placebo in reducing the incidence of subsequent heart attack, stroke or death due to cardiovascular events in patients with pre-existing cardiovascular disease. Given that the participants did not have a diagnosis of diabetes, the cardiovascular benefits of semaglutide are due to effects beyond the control of blood glucose levels.

As the patients in this study already had established cardiovascular disease, treatment with semaglutide only showed benefit when used for secondary prevention of heart attack and stroke. To date, there is no data that demonstrates a benefit from semaglutide in preventing the initial development of cardiovascular disease in individuals who do not have diabetes. Additionally, it is important to consider that approximately 75% of the enrollees in the current study were male and nearly 15,000 enrollees were white, so it is unknown if these results can be generalized to women or non-white patients. Further research is needed in determining the efficacy of semaglutide in a broader range of patient populations.

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Drug Safety

Voluntary Recall of Certain Over-the-Counter Drugs and Medical Devices

On October 5, 2023, Family Dollar announced a precautionary voluntary recall of certain over-the-counter medications and medical devices. The list of recalled products, which includes a wide array of common pain relievers, cough and cold medications, vitamins, toothpaste and personal hygiene products, can be found here. The affected items were stored outside of their labeled temperature requirements. They were sold in stores located in the following states between June 1 and October 4, 2023: AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY. This recall is occurring at the store level, and the impacted stores have been notified to check their stock and discontinue the sale of any affected product. Customers may return these products to the Family Dollar store where they were purchased. At this time, there have been no reported customer complaints or illness related to this recall, but customers are advised to contact their health care provider if they experience problems related to the use of these products. Adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program.

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From the Pharmaceutical Industry

Reviewing FDA Indications for GLP-1 Medications

The topic of weight loss and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) has recently gained increased attention in the media. There has been growing demand for these medications, but there have also been some misconceptions about the specific products and the FDA-approved indications for each. While early GLP-1 RA options were dosed once or twice daily, in recent years, once weekly injections have been approved for the treatment of diabetes to improve blood sugar control and provide cardiovascular benefit while affording the convenience of less frequent injections. It was observed through clinical trials and real-world experience that patients with diabetes experienced notable weight loss from these medications alongside the antidiabetic effects. This “side effect” results from appetite suppression and slowed movement of food through the gastrointestinal tract. Reduction of weight has been proven to decrease the risk of diabetes, hypertension and joint pain. It also encourages a more active lifestyle. As a result, manufacturers sought approval from the U.S. Food and Drug Administration (FDA) for new GLP-1 RA products to be used in weight reduction.

Ozempic® and Wegovy® both contain the same active drug, semaglutide. Ozempic® was approved in 2017 exclusively for the treatment of diabetes, and Wegovy® was approved in 2021 for use in weight reduction. Similarly, Mounjaro™ and Zepbound™ contain the same active ingredient, tirzepatide. Mounjaro™ was approved in 2022 to treat diabetes, and Zepbound™ was approved this month for use in weight loss. Although they will promote weight loss, it is not appropriate for Ozempic® or Mounjaro™ to be used exclusively for weight loss in individuals without diabetes as these dosage forms are reserved for patients who are managing their diabetes with these therapies. Inappropriate use for weight loss has led to many reported shortages of Ozempic® and Mounjaro™, affecting the medication regimens of patients with diabetes.

Before initiating therapy with a GLP-1 RA, patients should be aware of gastrointestinal side effects, such as nausea, vomiting and cramping that may occur from the use of these drugs for either indication. Patients and health care providers are advised to review medical history and weigh the risks and benefits of these medications to ensure safe and effective use.

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FDA Approvals

New FDA Approvals

New Drug: Fruzaqla™ (fruquintinib) for metastatic colorectal cancer

Oral capsule approved for the treatment of metastatic colorectal cancer in adult patients who have previously been treated with other specific drug therapies [11/08/2023 – TAKEDA PHARMS USA]

New Drug: Voquezna® (vonoprazan) for erosive esophagitis

Oral tablet approved for the treatment of erosive damage to the esophagus, also known as erosive gastroesophageal reflux disease (erosive GERD), in adult patients [11/01/2023 – PHATHOM PHARMACEUTICALS]

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New Generics

New Generics Entering the Marketplace

Votrient® (pazopanib)

Indication: Treatment of advanced renal cell carcinoma (a form of kidney cancer) or advanced soft tissue sarcoma (a cancer in the soft tissues of the body) in adult patients.

Dosage Form/Strength: 200mg tablet

Average Wholesale Price (AWP): Generic = $1,800 | Brand = $2,028