First Non-Profit Drug Developer Wins Approval for Cell-Based Therapy; New Sunscreen Ingredient Proposed; Triple-Strength Wegovy to be Fast-Tracked; Cancer, Kidney Disease Treatment Approvals, More
New Priority Voucher Drug includes Triple-Strength Wegovy
In October, we reported that the FDA had awarded the first nine “priority vouchers” for drugs that will receive expedited approval decisions. The first drug on that list has already been approved: an antibiotic, Augmentin XR (amoxicillin-clavulanate potassium), received approval for a version to be produced in the U.S.
FDA Press Release: “First Approval in Commissioner’s National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity”
(Check out patient experiences with Augmentin XR , often used for sinus infections, on Ask a Patient.)
Also, the FDA announced a second batch of drugs receiving priority vouchers. These include a higher strength (7.2 mg) version of Novartis’ weight loss drug Wegovy (semaglutide). The higher strength version is also under review in the European Union and the U.K. Currently the maximum strength of Wegovy contains just 2.4 mg of semaglutide per injection.
The five additional drugs in the second batch include:
Zongertinib for HER2 lung cancer, Bedaquiline for drug-resistant tuberculosis in young children, Dostarlimab for rectal cancer, Casgevy for sickle cell disease, and Orforglipron for obesity and related health conditions.
FDA Press Release: FDA Awards Second Batch of National Priority Vouchers
New Sunscreen Ingredient Proposed
The FDA is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens. Right now, only zinc and titanium dioxide are approved as GRASE (Generally Recognized as Safe and Effective). This may not sound right, as sunscreens are still on the market that contain chemical ingredients like Avobenzone, Oxybenzone, and Octocrylene. A proposed order by the FDA in 2022 recommended not including these chemicals as Generally Recognized as Safe and Effective, because more safety data was needed, but that proposed order has not yet been finalized, and those chemicals are still allowed in over-the-counter sunscreens.
Based on data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation. The ingredient is widely used in sunscreen products in other countries.
According to Dermatology Times, the proposal to add bemotrizinol was prompted by an “OTC Monograph Order Request” submitted by DSM Nutritional Products LLC, seeking authorization to use bemotrizinol at concentrations up to 6% in its over-the-counter sunscreen products. The American Academy of Dermatology (AAD), president Susan C. Taylor, MD, FAAD, “applauded the FDA for taking the first steps in more than 2 decades to provide more safe and effective sunscreen options to the American public.”2
FDA Press Release: “FDA Proposes Expanding Sunscreen Active Ingredient List”
Dermatology Times: FDA Proposes Expansion of US Sunscreen Ingredient Standards with Bemotrizinol
BEMT sunscreens may become available in summer or fall 2026 in the U.S., according to Today.
Two New “First in Class” Oral Antibiotics Approved for Gonorrhea
GlaxoSmithKline’s Blujepa (gepotidacin) tablets received expanded approval to treat uncomplicated gonorrhea (a sexually transmitted infection) in patients age 12 and up (weighing at least 99 pounds) who have limited treatment options. Blujepa is a first-in-class “triazaacenaphthylene” antibiotic, originally approved in March 2025 to treat urinary tract infections. The drug has a new warning about the risk of QTc Prolongation, or changes in electrical activity of your heart. Patients with a history of QTc interval prolongation, pre-existing cardiac disease, or patients taking antiarrhythmic agents should avoid taking the drug. Bluejepa has an FDA “clinical trials snapshot” available, which provides demographics (only women were in the trial) and outcomes for the first two clinical trials:
Clinical Trials Snapshot for Blujepa
The FDA also approved Entasis Therapeutics’ Nuzolvence (zoliflodacin) for uncomplicated gonorrhea in patients age 12 and up (weighing at least 77 pounds). The medication, a first-in-class “Spiropyrimidinetrione” antibiotic, consists of granules that dissolve in water. Uncomplicated gonorrhea infection is localized to the urethra or cervix and has not spread to other areas of the body. Left untreated, it could lead to widespread infection of the reproductive organs and infertility.
FDA Press Release: “FDA Approves Two Oral Therapies to Treat Gonorrhea”
New Drug for IgAN Kidney Disease
The FDA granted accelerated approval for Otsuka Pharmaceutical’s Voyxact (sibeprenlimab-szsi) subcutaneous injection to reduce proteinuria (protein in the urine) in adults with Immunoglobulin A nephropathy (IgAN) at risk for disease progression. IgAN is a kidney disease that causes protein to leak into the urine and may lead to kidney function decline. The disease is often diagnosed in young adults. As a condition of the accelerated approval, the ongoing trial must be completed to confirm that Voyxact slows kidney function decline over the long-term. The medication is administered by self-injection every four weeks.
FDA Press Release: FDA Approves New Treatment for Primary Immunoglobulin Nephropathy
Fierce Pharma: “In crowded kidney disease space, Otsuka receives FDA approval for first-in-class Voyxact”
New Gastric Cancer Treatment
Imfinzi (durvalumab) injection, for intravenous use, received expanded approval for treating gastric cancer and gastroesophageal cancer. Imfinzi is an immunotherapy that treats lung, bladder, and other types of cancers, often in conjunction with chemotherapy. It was originally approved in 2017.
FDA: FDA Letter of Approval
Imfinzi Revised Drug Label
New Lymphoma Approval for Breyanzi Cell Therapy
The FDA expanded the approval of Juno Therapeutics’ (Bristol Meyers Squibb) Breyanzi (lisocabtagene maraleucel) to treat adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy. Breyanzi is a “CAR-T” cell therapy, a type of immunotherapy, that genetically engineers a patient’s own immune system’s T-cells to target and kill cancer cells.
Marginal zone lymphoma is a rare, slow-growing cancer of the lymphatic system. It represents about 7% of all B-cell non-Hodgkin lymphoma, with approximately 7,460 new cases diagnosed in the U.S. each year. Breyanzai was originally approved in 2021 to for prior treatment-resistant relapsed or refractory large B-cell lymphoma, a more common type of blood cancer that develops in white blood cells. Breyanzai is one of just 48 gene or cell therapies approved in the U.S.
FDA: Breyanzi Approval
Read more about B-cell lymphoma and Marginal Zone Lymphoma at Cleveland Clinic.
Cellular Therapy for Severe Aplastic Anemia
Gamida Cell Ltd.’s Omisirge (omidubicel-onlv) received approval to treat Severe Aplastic Anemia, a rare condition where the bone marrow fails to produce sufficient blood cells, including red cells, white cells, and platelets. Stem cells become damaged, often due to the immune system attacking them.
FDA Press Release: FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia
Nonprofit Drug Developer Receives FDA Approval for Wiskott-Aldrich Syndrome Treatment
Fondazione Telethon ETS’s Waskyra (etuvetidigene autotemcel) was approved as the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). WAS is an inherited (X-linked) immunodeficiency disease that affects about one in every 250,000 males and is characterized by bleeding, eczema, recurrent infections, and susceptibility to blood-related cancers. Waskyra treatment consists of the patient’s own blood stem cells, which have been genetically modified to include corrected copies of the WAS gene. Without treatment, many boys with WAS have a life expectancy of only nine to fourteen years. Patients successfully treated with bone marrow transplants (previously the only treatment available) have gone on to lead normal lives, but often a suitable donor cannot be found, according to the Wiskott-Aldrich Foundation. The FDA notes that this is this is a first approved cell and gene therapy product from a non-profit applicant.
FDA Press Release: FDA Approves First Gene Therapy Treatment for Wiskott Aldrich Syndrome
The disease was named for the work of Dr. Alfred Wiskott, a World War I veteran and physician, and Dr. Robert Aldrich, an American pediatrician who studied six generations of a Dutch family affected with the illness.
“The Week”: Has Science Finally Found a cure for Wiskott Aldrich Syndrome?
New Gene Therapy for Spinal Muscular Atrophy
The FDA approved Novartis’ gene therapy Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in the survival motor neuron 1 (SMN1) gene. Novartis states that “Itvisma is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma can improve motor function, offering the potential to reduce the need for chronically administered treatment associated with other available therapies for this population.” Itvisma has a boxed warning about the risk of liver injury.
FDA Press Release FDA Approves Gene Therapy Treatment for Spinal Muscular Atrophy
Novartis press release: Novartis receives FDA approval for Itvisma
Muscular Dystrophy Association: “What is Spinal Muscular Atrophy?”
Two newsletters were sent today. In addition to this New Drug Approvals feature, a separate post (sent after this one) features Drug Safety Updates with warnings and recalls:
https://news.askapatient.com/p/new-warnings-for-ra-drug-actemra
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