Pulse Newsletter | Volume 8 - Issue 4

FDA Approves Targeted Oral Peptide to Treat Plaque Psoriasis

On March 17, 2026, the U.S. Food and Drug Administration (FDA) approved Icotyde™ (icotrokinra) tablets for the treatment of adult and pediatric patients 12 years and older who weigh at least 88 pounds with moderate-to-severe plaque psoriasis (a chronic autoimmune disorder of the skin causing raised and inflamed areas of scaly patches of skin). Icotyde™ recommended dosage is one tablet (200mg) taken by mouth daily in the morning on an empty stomach. Patients should then wait 30 minutes before eating. Warnings and precautions of Icotyde™ include avoiding treatment in patients with active infections or tuberculosis (TB). Patients should not receive live vaccines during treatment with Icotyde™. The most common side effects are headache, nausea, cough, fungal infection and fatigue.

The safety and efficacy of Icotyde™ was studied in four randomized, double-blind clinical trials with a total of 2,500 patients ages 12 and older with psoriasis. A primary endpoint for two of the clinical trials was a 2-grade or greater improvement in the patient’s Psoriasis Area and Severity Index (PASI) score; a tool used to measure psoriasis disease severity. Based on the results of one study, 55% of patients given Icotyde™ achieved a PASI 90 score (at least 90% improvement from baseline), compared to 4% for placebo and 30% for patients given an active comparator, deucravacitinib (the active ingredient in Sotyktu®). Icotyde™ is not yet commercially available in the United States and pricing information has not yet been made public.

FDA Launches New Adverse Event Look-Up Tool

On March 11, 2026, the FDA announced a new online platform for collecting and analyzing adverse drug events called the FDA Adverse Event Monitoring System (AEMS). The new system will streamline the collection of adverse event information pertaining to food, vaccine, tobacco, drug, dietary supplements and medical device products. The information is currently housed in seven different individual databases (the FDA Adverse Event Reporting System, Vaccine Adverse Event Reporting System, Adverse Event Reporting System, Manufacturer and User Facility Device Experience, Human Foods Compliant System, Center for Tobacco Products Adverse Event Reporting System and MedWatch Reports), which will be integrated into one platform by the end of May 2026, making it easier for users to access the information and increasing transparency. The platform is expected to improve the rate at which users can access adverse event information by providing the information in real time for all FDA-regulated products, rather than providing quarterly data reports, as is currently being done. Any individuals including patients, caregivers and healthcare professionals, can submit an adverse event report using the database.

According to the FDA, about 6 million adverse event reports are processed per year across the seven databases, with a cost of about $37 million to the federal government to operate. The FDA anticipates significant savings, about $120 million over five years, by integrating into one platform.

Medicare Announces Third Cycle of Drug Price Negotiations

On March 13, 2026, the Centers for Medicare & Medicaid Services (CMS) announced the drug names and participating drug manufacturers that will be participating in the third round of Medicare drug price negotiations. The Medicare Drug Price Negotiation Program, which was established as part of the Inflation Reduction Act in 2022, has already completed two rounds of drug price negotiations, with the first round of 10 drug prices going into effect on January 1, 2026, and the second round of 15 drug prices going into effect on January 1, 2027. The brand name drugs selected for the program are based on utilization among Medicare members and associated cost, with the estimated cost being around $27 billion for the drugs selected for this round.

The participating drugs in the third cycle are Anoro Ellipta®, Biktarvy®, Botox®, Cimzia®, Cosentyx®, Entyvio®, Erleada®, Kisqali®, Lenvima®, Orencia®, Rexulti®, Tradjenta®, Trulicity®, Verzenio®, Xeljanz® and Xolair®. These drugs treat various disease states, including several autoimmune disorders (such as Crohn’s disease, rheumatoid arthritis, psoriasis, psoriatic arthritis), cancers, type 2 diabetes, migraines, chronic obstructive pulmonary disease, asthma, HIV, schizophrenia and major depressive disorder. Negotiations will be completed by November 1, 2026, and the final pricing for these 15 drugs will take effect on January 1, 2028. Of note, the third round of negotiations includes Botox, a physician-administered drug typically covered under Medicare Part B (medical insurance) rather than Part D (drug coverage), which covers most prescription drugs. 

New FDA Approvals

New Drug: Lynavoy™ (linerixibat)

Oral tablets approved for the treatment of cholestatic pruritus (severe itching caused by liver disease) associated with primary biliary cholangitis (a chronic autoimmune liver disease that causes a buildup of bile) in adult patients. [3/17/2026 – GlaxoSmithKline, LLC.]

New Generics Entering the Marketplace

Savella^® (milnacipran HCl)

Indication: For the management of fibromyalgia (a chronic pain disorder) in adult patients.

Dosage Form/Strength: 12.5mg, 25mg, 50mg, 100mg tablets

Average Wholesale Price (AWP): Generic = $550/month | Brand = $600/month