Pulse Newsletter | Volume 8 - Issue 7

FDA Approves New Drug for COVID-19 Post-Exposure Prevention

On May 29, 2026, the U.S. Food and Drug Administration (FDA) approved Xocova^® (ensitrelvir) tablets for post-exposure prevention of coronavirus disease 2019 (COVID-19) in adult and pediatric patients 12 years and older who have had contact with an individual with COVID-19 disease. Xocova^® therapy should be started as soon as possible following contact with an individual with COVID-19 disease (within the first 72 hours). Xocova^® is a five-day regimen, beginning with one dose of 375mg (three tablets) taken by mouth on Day One, then 125mg (one tablet) taken by mouth once a day for the next four days. Xocova^® may be taken with or without food. Xocova^® should not be used during pregnancy due to risk of harm to an unborn baby. The most common side effects associated with Xocova^® therapy are headache, diarrhea and cough. Certain other drugs should not be taken with Xocova^® as they may cause a severe or life-threatening interaction if taken together. These include certain prescription and over-the-counter medications, such as quinidine, phenytoin, carbamazepine, colchicine, lurasidone, eplerenone, ivabradine, simvastatin and others. 

The safety and efficacy of Xocova^® was established in the SCORPIO-PEP trial, which was a double-blind, placebo-controlled clinical trial of 2,377 patients 12 and older who tested negative for COVID-19 infection and lived in a household with an individual with COVID-19 infection. The primary endpoint of the clinical trial was whether the study patient exhibited symptoms (for at least 48 hours) of COVID-19 infection within 10 days of receiving either Xocova^® therapy or placebo. The trial met the primary endpoint as patients treated with Xocova^® were less likely to experience symptoms of COVID-19 infection compared to those treated with placebo.

FDA Approves Label Change for Over-the-Counter Weight Loss Drug Alli Due to Risk of Kidney Injury

On June 10, 2026, the FDA announced a package label change to the drug Alli^® (orlistat) 60mg capsules, which is FDA-approved for weight loss in adults (along with a reduced calorie and low-fat diet) and available to purchase over the counter without a prescription. The warning is for risk of kidney injury and kidney stones (hard deposits of salts and minerals that form in the kidneys when the urine becomes too concentrated and can get stuck in the urinary tract if they get too large, causing intense pain), which may be a rare side effect associated with use of Alli®. Patients are advised to discontinue Alli^® and contact their doctor or other health care provider if they experience symptoms of kidney injury or kidney stones, including blood in the urine, pain when urinating, back or groin pain, swelling in the feet or legs or less frequent urination.

The change to the package labeling for Alli^® comes after the FDA identified 12 cases of severe kidney injury, with some patients requiring hospitalization or dialysis, after reviewing the Adverse Event Monitoring System (AEMS), along with available drug literature. Alli^® also contains a warning that it should not be used in patients who have had an organ transplant as it may interfere with other medications they are taking to prevent transplant rejection. Per the package labeling, the recommended dose of Alli^® is one capsule (60mg) taken by mouth with each meal, with no more than three capsules taken per day. The active ingredient in Alli^®, orlistat, is also available as a prescription drug, called Xenical, which comes in a higher strength 120mg capsule. Prescription Xenical also contains a warning to monitor kidney function due to the risk of kidney stones.

Investigational Triple Hormone Receptor Agonist Demonstrates Weight Loss Comparable to Bariatric Surgery

Drug company Eli Lilly is sharing clinical results of their investigational new drug, retatrutide, which is a once-weekly subcutaneous (under the skin) injectable triple hormone receptor agonist. The drug targets receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1) and glucagon. Retatrutide is not yet FDA-approved and is still being studied in Phase 3 clinical trials for treatment of various disease states, including obesity, type 2 diabetes, obstructive sleep apnea (OSA), chronic low back pain and osteoarthritis of the knee.

Lilly shared some of their clinical data regarding initial weight loss results in study subjects taking retatrutide at the 2026 American Diabetes Association’s (ADA) annual meeting. Results shared from the TRIUMPH-1 Phase 3 clinical trial with study subjects taking retatrutide for weight loss indicated that participants lost about 28% of their body weight after 80 weeks of therapy and up to 30% weight loss after 104 weeks of therapy on the highest dose (12mg) of retatrutide, comparable to results seen after bariatric surgery. Patients also demonstrated improvements in lab values including reduced cholesterol and triglycerides and lower blood pressure. Preliminary safety data for retatrutide indicates mainly gastrointestinal side effects, such as nausea, constipation and diarrhea, which are common with other GLP-1 medications. In a separate clinical trial, TRANSCEND-T2D-1, patients with type 2 diabetes treated with retatrutide achieved an A1C (a blood test that measures a person’s average blood sugar levels over a 3-month period) reduction of about 2% after 40 weeks of therapy, with about 90% of patients achieving an A1C below 7%, the goal set by the ADA for patients with type 2 diabetes. Retatrutide is expected to be available by late 2027 or 2028, pending FDA approval.

New FDA Approvals

New Drug: Utebzi (tebipenem pivoxil)

Oral tablets approved for the treatment of adult patients with complicated urinary tract infections (cUTI). [6/17/2026 – GlaxoSmithKline, LLC]

New Generics Entering the Marketplace

Xeljanz^®/Xeljanz^® XR (tofacitinib)

Indication: For the treatment of several auto-immune diseases, including psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and ankylosing spondylitis.

Dosage Form/Strength: 1mg/ml solution; 5mg, 10mg tablets; 11mg, 22mg extended-release tablets

Average Wholesale Price (AWP): Generic = $4,500 - $6,900/month | Brand = $5,500 - $7,700/month