Pulse Newsletter | Volume 8 - Issue 1

FDA Approves New Drug for Treatment of Severe Asthma with an Eosinophilic Phenotype

On December 16, 2025, the U.S. Food and Drug Administration (FDA) approved Exdensur (depemokimab-ulaa) subcutaneous injection for add-on therapy for the treatment of severe eosinophilic type asthma in patients 12 years and older. Exdensur is supplied as a 100mg/ml single-dose prefilled pen or syringe that is stored in the refrigerator in the original packaging to protect the medication from light and is administered subcutaneously (under the skin) by a health care provider once every 6 months into the upper arm, thigh or abdomen. Exdensur may be kept at room temperature, but only for 7 days. Warnings and precautions of Exdensur include risk of allergic reaction including anaphylaxis (a severe, potentially life-threatening, allergic reaction that can occur after exposure resulting in narrowed airways and difficulty breathing). The most common side effects associated with therapy include common cold, sinus infection, sneezing, runny nose, nasal congestion, flu, joint pain, sore throat and injection site reactions (such as mild pain, itching, swelling).

The safety and efficacy of Exdensur as add-on therapy for eosinophilic asthma was studied in two randomized, double-blind, placebo-controlled, multi-center 52-week trials with 762 patients ages 12 and older. Participants received either Exdensur 100mg subcutaneous injection once every 6 months or placebo. The primary clinical endpoint in the trials was the annualized rate of significant asthma exacerbations, defined as an exacerbation requiring the use of intravenous or oral steroids for at least 3 days, or a single intramuscular steroid dose, or hospital or emergency room (ER) visit. The annualized rate of severe asthma exacerbations was lower in patients treated with Exdensur (32%) versus placebo (46-50%), as well as the percentage of patients requiring hospital or ER visit (1-4% for Exdensur compared to 8-10% for placebo). The average wholesale price of Exdensur is approximately $31,200 per dose.

FDA Qualifies Total Hip Bone Mineral Density as Surrogate Endpoint for Osteoporosis Drug Development

On December 19, 2025, the FDA announced that hip bone mineral density (BMD) will be an acceptable endpoint for clinical trials to support the emergence of new therapies for the treatment of osteoporosis in post-menopausal women at high risk for bone fracture. A BMD test uses a low-dose X-ray (DEXA scan) to measure the amount of calcium and other minerals in the bones, which can be used to diagnose osteoporosis and determine fracture risk. Previously, clinical trials used fractures as a clinical endpoint to assess drug safety and efficacy. According to the FDA, the average length of a clinical trial for osteoporosis drugs using the fracture clinical endpoint is 2-5 years. By utilizing the hip BMD, the intent is to expedite clinical trials and enable quicker FDA approval to generate alternative treatments for patients.

Osteoporosis is a bone disease where bones weaken over time and become more brittle, increasing the risk of fractures and injury if a patient has a fall. Women are more likely to be diagnosed with osteoporosis, and risk increases with age, especially after menopause, which typically occurs around age 50. In the United States, there are approximately 10 million patients ages 50 and older with osteoporosis, 80% of these patients are women. Other risk factors include diet low in calcium, smoking and increased alcohol use. Lifestyle changes can help reduce the risk of fall, including diet adequate in calcium and vitamin D, exercises to strengthen bones, fall prevention and the removal of tripping hazards in the home. Current medication treatment options for osteoporosis include oral bisphosphonates, such as alendronate, ibandronate and risedronate, and injectable medications, such as teriparatide, Prolia and Prolia biosimilars.

Oral Weight Loss Medication Gains FDA Approval

On December 22, 2025, the FDA approved Wegovy® (semaglutide) oral tablets, the first oral GLP-1 medication to be approved for weight loss in adults. Wegovy® was previously only available in a once weekly subcutaneous injection, approved for treatment of weight loss in conjunction with diet and exercise in patients 12 years and older, metabolic dysfunction-associated steatohepatitis (MASH) in adult patients and for the reduction of risk of major cardiovascular events (MACE) in adult patients with established cardiovascular disease. Wegovy® tablets are available in 1.5mg, 4mg, 9mg and 25mg strengths and are FDA-approved for use in adults for weight reduction in conjunction with diet and exercise and for the reduction of risk of major cardiovascular events (MACE) in patients with cardiovascular disease. The recommended dose is 1.5mg once daily for the first 30 days of therapy, followed by monthly dose increases (4mg then 9mg), until the target maintenance dose of 25mg once daily is reached. Wegovy® tablet is recommended to be taken once daily in the morning with water on an empty stomach at least 30 minutes before eating, drinking or taking other medications.

The efficacy of Wegovy® tablets was established in a 64-week clinical trial of 307 adults who were overweight or obese with a BMI of at least 27kg/m² and at least one comorbid medical condition, such as high blood pressure or high cholesterol. Patients treated with Wegovy® tablets, in conjunction with reduced calorie diet and increased exercise, resulted in an average of 14% weight loss, compared to 2% weight loss with placebo. Per the product package insert, adult patients using Wegovy® 2.4mg injection for reduction of risk of MACE or for weight loss may switch to Wegovy® 25mg tablets one week after their last injection.  Adult patients who cannot tolerate Wegovy® 25mg tablet maintenance dose may consider switching to 1.7mg injection once weekly but not the lower strength tablets as they are not established as effective for maintenance use. The list price of Wegovy® 25mg tablet is $1,349 per month however Novo Nordisk is introducing discount programs for patients that to not have prescription coverage.   

New FDA Approvals

New Drug: Lerochol™ (lerodalcibep-liga)

Subcutaneous injection approved as an adjunct to diet and exercise to lower low-density lipoprotein cholesterol (LDL-C), also known as “bad” cholesterol, in adult patients diagnosed with high cholesterol. [12/12/2025 – LIB Therapeutics, Inc.]

New Generics Entering the Marketplace

Rayos® (prednisone)

Indication: For use in various allergic, skin, gastrointestinal, respiratory, blood, eye, nervous system, kidney, joint and hormone conditions to reduce inflammation or suppress the immune system.

Dosage Form/Strength: 1mg, 2mg, 5mg delayed-release tablets

Average Wholesale Price (AWP): Generic = $2,800/tablet | Brand = $3,300/tablet