Pulse Newsletter | Volume 8 - Issue 8

FDA Approves First Oral PCSK9 Inhibitor to Reduce LDL Cholesterol in Adults

On July 15, 2026, the U.S. Food and Drug Administration (FDA) approved Lipfendra^® (enlicitide) tablets, to be used in conjunction with lifestyle modifications including diet and exercise, to lower low-density lipoprotein (LDL) cholesterol in adults with high cholesterol. Lipfendra^® can be used as add-on therapy with statins (e.g., atorvastatin, pravastatin and rosuvastatin), which are another type of drug commonly prescribed to lower LDL cholesterol. High cholesterol occurs when there are too many lipids (fats) in the blood, leading to the formation of plaque in the arteries, which increases risk of cardiovascular disease, including heart attack and stroke. Lowering LDL cholesterol reduces the risk for major adverse cardiovascular events (MACE). The recommended dose of Lipfendra^® is one tablet (20mg) taken by mouth once per day in the morning on an empty stomach with water, black coffee or plain tea. Patients should wait at least 30 minutes after taking Lipfendra^® before eating or drinking anything other than water, black coffee or plain tea. The most common side effects associated with Lipfendra^® are diarrhea and dizziness.

The safety and efficacy of Lipfendra^® was established in two multi-center, double-blind, randomized, placebo-controlled clinical trials with over 3,000 adult patients with high cholesterol. The primary outcome measure was percent change from baseline LDL cholesterol at week 24. For Trial 1 and Trial 2, LDL cholesterol was reduced by 56% and 59%, respectively, for patients in the Lipfendra^® group, compared to an increase of 3% in LDL for patients in the placebo group of both trials. Lipfendra^® is the first available oral PCSK9 inhibitor. Other PCSK9 inhibitors, including Repatha^® (evolocumab) and Praluent^® (alirocumab), are injectable prescription medications. Lipfendra^® is not yet available in the United States. The anticipated cost of Lipfendra^® is around $315 a month, which is less than Repatha^® and Praluent^®, which cost about $500-$600 a month.

Beekeeper’s Naturals Voluntarily Recalls Saline Nasal Spray

On June 12, 2026, the FDA announced a recall of Beekeeper’s Naturals saline nasal spray due to microbiological contamination with yeast and potential mold (Aspergillus, a type of mold). The recalled product is sold in a 30 mL bottle with a lot number of 5950 and expiration date of 02/2028. The lot number and expiration date can be found on the bottom or back side of the packaging. The product was sold online to consumers through Amazon between the dates of April 2-24, 2026, according to information on the FDA’s website. Consumers who purchased this item have been notified of the recall by Beekeeper’s Naturals. Using a product contaminated with mold could cause serious life-threatening sinus or lung infections, especially in high-risk individuals with compromised immune systems or chronic lung diseases.

According to Beekeeper’s Naturals, to date there have been four consumer reports of experiencing adverse effects after using the saline nasal spray. These adverse effects include sinus congestion, sinus irritation or sinus infection. Consumers who may have purchased contaminated lots of Beekeeper’s Naturals saline nasal spray are advised to discontinue using the product. Consumers with questions can contact Beekeeper’s Naturals directly by phone at 1-888-759-6910, Monday-Friday, 8 a.m. to 8 p.m. ET. The company is offering impacted consumers a refund. Consumers can report adverse effects with this product, or any other prescription or over-the-counter drug product, using the FDA’s MedWatch Adverse Event Reporting program. Anyone experiencing a health problem related to the use of contaminated Beekeeper’s Naturals saline nasal spray should contact their health care provider.

Investigational GLP-1 Implant Being Studied to Help Patients Maintain Weight Loss

Drug company Vivani Medical, in agreement with Novo Nordisk, is developing an experimental long-acting semaglutide implant, currently known as NPM-139, that it believes will help improve patient adherence to GLP-1 medications. The investigational implant would require an in-office appointment to be implanted subcutaneously (under the patient’s skin) by a doctor once or twice a year. It could potentially be used as a maintenance dose once a patient is established on initial GLP-1 therapy. According to Vivani Medical, the implant would be capable of delivering different doses of semaglutide through a special membrane with microscopic “straws” through which the drug would travel from the implant’s reservoir into the body at a slow, steady rate.

Semaglutide is the active ingredient in the GLP-1 drugs Ozempic^®, which is FDA-approved for the treatment of type 2 diabetes, and Wegovy^®, which is FDA-approved for weight loss in adult and pediatric patients ages 12 and older, along with treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults and reduction of risk of major adverse cardiovascular events (MACE) in adults. According to several studies, it is estimated that about 50% of individuals taking GLP-1 medications for weight loss stop taking the medication within a year and, therefore, may gain back the weight they lost. Contributing factors to discontinuation of weight loss GLP-1s include high cost to the patient and adverse effects (most common are nausea, diarrhea, vomiting, constipation, flatulence and stomach pain). The implant is currently investigational, as further clinical study is needed to determine safety and efficacy prior to submission to the FDA for approval. Vivani Medical began phase 1 human studies in mid-2026 with about 20 participants who will be randomized to receive either the GLP-1 implant or Wegovy^® injection over a period of four weeks. The projected cost of the implant is not known, but other weight loss GLP-1 drugs can cost up to $16,000 per year.

New FDA Approvals

New Drug: Trutakna^™ (atacicept-vymj)

Subcutaneous (under the skin) injection approved to reduce proteinuria (too much protein in the urine that can lead to kidney damage) in adults with primary immunoglobulin A nephropathy (IgAN), a rare type of autoimmune kidney disease. [7/7/2026 – Vera Therapeutics, Inc.]

New Generics Entering the Marketplace

Rhofade^® (oxymetazoline hydrochloride)

Indication: For the treatment/prevention of rosacea (a chronic inflammatory skin condition causing redness, primarily on the face) in adults. 

Dosage Form/Strength: 1% topical cream

Average Wholesale Price (AWP): Generic = $650/30-gram tube | Brand = $850/30-gram tube