Pulse Newsletter | Volume 8 - Issue 5

FDA Approves New Oral Drug for Treatment of Obese and Overweight Adults

On April 1, 2026, the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) tablets, a GLP-1 receptor agonist, in combination with diet and exercise, for weight loss in obese and overweight adult patients. Foundayo™ is not approved for use in pediatric patients. Foundayo™ is an oral medication taken once a day with or without food. The starting dose is 0.8mg once daily, then the dose is gradually increased every 30 days to 2.5mg, then 5.5mg per day. The maintenance dose (9mg, 14.5mg or 17.2mg once daily) is based on patient response and tolerability to side effects. The most common side effects seen in clinical trials with Foundayo™ were gastrointestinal, including nausea, vomiting, constipation, diarrhea, gastroesophageal reflux disease (GERD), flatulence and stomach pain. Other side effects included headache, fatigue and hair loss.

The safety and efficacy of Foundayo™ was established in two randomized, double-blind, placebo-controlled clinical trials of 4,740 adult patients with a body mass index (BMI) of at least 27kg/m² and at least one weight-related comorbid condition, such as high blood pressure, high cholesterol, obstructive sleep apnea or cardiovascular disease. The primary endpoint was the percentage of body weight reduction from baseline weight after 72 weeks of therapy. In both clinical trials, weight loss was statistically significant in the Foundayo™ group compared to the placebo group. Patients taking Foundayo™ achieved an average weight loss of 11.1% from baseline on the 17.2mg daily dose, compared to 2.1% weight loss for the patients on placebo. The list price of Foundayo™ is $649 per month, with patient support programs available for self-paying consumers through LillyDirect®.

FDA Announces Acceleration for Studies of Investigational New Treatments for Serious Mental Illness

On April 24, 2026, the U.S. Department of Health and Human Services (HHS) announced that pursuant to an Executive Order signed by President Donald J. Trump on April 18, 2026, the FDA will accelerate action to review and potentially approve investigational new drug therapies intended for the treatment of serious mental illnesses, including treatment-resistant depression and substance abuse disorders. The investigational psychedelic drugs, called serotonin-2A receptor agonists, work by activating serotonin receptor activity in the brain, leading to rapid and long-lasting antidepressant effects. According to national statistics, over 14 million adults in the United States have a serious mental illness, defined as interfering with a person’s ability to conduct activities of daily living. An increase in social isolation, depression and anxiety due to the COVID-19 pandemic led to an increase in prevalence of mental health disorders, including among the U.S. veteran population, who remain at higher risk.

Despite the availability of many prescription therapies, including antidepressants, antipsychotics and mood stabilizers, there remains an unmet need for alternative therapies to address the most complex patient cases that may be unresponsive or suffer relapses on standard therapy. The FDA has granted priority review for pharmaceutical companies studying psilocybin and methylone for treatment-resistant depression and post-traumatic stress disorder (PTSD), as well as a clinical study of ibogaine for treatment of alcohol use disorder. It is important to note that these therapies have not yet been found to be safe and effective and additional clinical studies are needed before these therapies are reviewed for FDA approval.

CMS Announces Proposed Major Reforms to Improve Patient Access to Drugs

On April 10, 2026, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule designed to increase the speed, efficiency and transparency at which drug prior authorizations are reviewed for Medicare members. The 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule (CMS-0062-P) would require compliance with information technology (IT) updates as well as public reporting requirements, effective October 1, 2027. Proposed technology updates include the utilization of application programming interfaces (APIs) to allow Medicare patients and their providers to access their prior authorization information in real time, such as prior authorization status, date approved or denied and detailed reason(s) for denial. Reporting requirements would include overall approval and denial rates for prior authorizations and appeals and prior authorization turnaround times.

The intent of the new regulation is to improve transparency as well as allow potential Medicare recipients to more easily compare the performance of different plans based on publicly available reporting. It would build on CMS’ Interoperability and Prior Authorization final rule, put in place in 2024, which was designed to eliminate prior authorization requirements for certain specific medical and diagnostic Part B services and make healthcare for Medicare recipients easier and reduce potential barriers to receiving care. 

New FDA Approvals

New Drug: Idvynso™ (doravirine and islatravir)

Oral tablets approved for the treatment of HIV-1 infection in adult patients. [4/20/2026 – Merck Sharp & Dohme, LLC.]

New Generics Entering the Marketplace

Nitro-Bid^® (nitroglycerin)

Indication: For the prevention of angina pectoris (chest pain caused by reduced blood flow to the heart muscle) due to coronary artery disease.

Dosage Form/Strength: 2% ointment

Average Wholesale Price (AWP): Generic = $50/30gm tube | Brand = $90/30gm tube