Pulse Newsletter | Volume 8 - Issue 6

FDA Approves First Aldosterone Synthase Inhibitor for Treatment of Hypertension in Adults

On May 15, 2026, the U.S. Food and Drug Administration (FDA) approved Baxfendy™ (baxdrostat) tablets for the treatment of hypertension (high blood pressure) in adults who are currently taking other medications to lower blood pressure and are still not controlled. Baxfendy™ is the first aldosterone synthase inhibitor (ASI) approved by the FDA to lower blood pressure. It works by blocking the body’s production of aldosterone, a hormone that can raise blood pressure above normal, healthy levels by causing the kidneys to retain sodium, leading to increased water in the blood and greater blood volume. Having uncontrolled high blood pressure damages blood vessels and vital organs and increases a person's likelihood of cardiovascular disease and adverse events, such as heart attack, stroke and kidney failure.

The safety and efficacy of Baxfendy™ was evaluated in a Phase III 12-week, double-blind, multicenter clinical trial in adults with hypertension taking two or more blood pressure medications. The primary endpoint in the trial was change in systolic blood pressure (SBP), comparing Baxfendy™ to placebo. Baxfendy™ was given in doses of 1mg or 2mg per day, and this led to decreases in SBP of 15mmHg and 16mmHg, respectively. When compared to placebo, which resulted in a 6mmHg decrease in SBP, both doses of Baxfendy™ demonstrated a statistically and clinically significant improvement in blood pressure. The recommended dose of Baxfendy™ is 2mg taken by mouth once a day with or without food. If patients are at risk for high potassium levels or low sodium levels, the dose may be reduced to 1mg taken by mouth once a day. The most common side effects associated with treatment with Baxfendy™ is high potassium levels. Baxfendy™ is currently available in the United States at a list price of $900 per month.

Insulet Announces Voluntary Recall of Certain Omnipod^® Pods

On May 26, 2026, Insulet Corporation announced an urgent voluntary recall of certain lots of their Omnipod^® pods due to an identified manufacturing issue, according to the company's website. Omnipod^® pods provide insulin delivery through a reservoir or pod that is filled with insulin and attached to the body for up to three days. The pod contains a small, soft, flexible tube (called a cannula) that delivers the insulin into the body, just under the skin. Insulet found that some pods in specific lots may have a small tear in the cannula between the pod and where the tube enters the skin. As a result of the tear, insulin may leak from the tubing and, therefore, the full intended dose may not be delivered. Patients may notice wetness on the skin due to the leaking insulin, but the leak may be difficult to observe and may not be easily identified. Under-dosing of insulin could result in blood sugar levels increasing, which can be dangerous over time and potentially lead to a serious life-threatening condition called diabetic ketoacidosis (DKA) if the body lacks enough insulin and experiences a prolonged episode of high blood glucose levels.

Insulet advises users to check the lot numbers of their pods and to discontinue use of any pod that is impacted by the recall. Manufacturer communications to affected customers provides instructions on obtaining replacement pods at no cost. The company stated that Omnipod^® pods not impacted by recall are safe to use. Consumers may contact Insulet directly with questions by using their product support line, 1-800-641-2049, or report any issues to the FDA’s MedWatch Adverse Events Reporting program online.

CMS Will Soon Provide $50 Monthly Access to Certain GLP-1 Drugs for Medicare Members

On May 6, 2026, the Centers for Medicare & Medicaid Services (CMS) released additional information regarding coverage of certain GLP-1 drugs for weight loss for eligible Medicare members. Beginning on July 1, 2026, CMS will launch the GLP-1 Bridge pilot program to provide access to GLP-1 drugs for weight loss. Drugs used for weight loss are currently excluded from coverage under Medicare plans. The GLP-1 Bridge program, which will run through December 31, 2027, will expand access for Medicare members and provide GLP-1 drugs for weight loss at a cost of $50 per month to eligible Medicare members enrolled in a Part D prescription drug plan. To qualify for coverage of a GLP-1 drug for weight loss through the GLP-1 Bridge program, members must have their doctor, or other qualified healthcare provider, submit a prior authorization request to a Central Processor on or after July 1, 2026 and a prescription that   meets certain prior authorization criteria, as determined by CMS.

Prior authorization criteria include prescribing that is consistent with FDA-approved package labeling (to achieve weight loss in combination with diet and exercise), age of 18 years or older and body mass index (BMI) of at least 35kg/m² unless other conditions exist. Medicare members would qualify with a BMI of at least 30kg/m² if they carry a diagnosis of heart failure with preserved ejection fraction, uncontrolled high blood pressure (despite treatment with two medications to treat high blood pressure) or chronic kidney disease stage 3a or higher. Members can qualify with a BMI as low as 27kg/m² if they hold a diagnosis of pre-diabetes, previous history of heart attack, previous stroke or symptomatic peripheral artery disease. Eligible GLP-1 drugs used for weight loss that will be available through the GLP-1 Bridge program include Wegovy^®, Zepbound^®, and Foundayo™.

New FDA Approvals

New Drug: Hepcludex^® (bulevirtide-gmod)

Subcutaneous (under the skin) injection approved for the treatment of adult patients with chronic hepatitis D infection, a severe liver disease caused by the hepatitis delta virus (HDV), without cirrhosis or with compensated cirrhosis. [5/22/2026 – Gilead Sciences, Inc.]

New Generics Entering the Marketplace

Astagraf XL^® (tacrolimus)

Indication: For the prevention of organ rejection in adult and pediatric kidney transplant patients.

Dosage Form/Strength: 0.5mg, 1mg, 5mg extended-release capsules

Average Wholesale Price (AWP): Generic = $1,000/month | Brand = $1,075/month