OTC Glucose Monitor
The FDA has cleared Dexcom Stelo Glucose Biosensor System for over-the-counter (OTC) sale, a first in the agency’s history for a continuous glucose monitor (CGM). This clearance follows Dexcom’s submission of the application on January 8, 2024. The Dexcom Stelo sensor is designed for individuals aged 18 and older who do not use insulin. This includes people with diabetes managing their condition with oral medications and those without diabetes who are interested in understanding how their diet and exercise impact blood sugar levels. The system, however, is not intended for individuals with problematic hypoglycemia as it does not alert users to this potentially dangerous condition. Dexcom’s Stelo offers a 15-day sensor wear time and a software experience tailored for non-insulin users, with plans to launch the product in Summer 2024. The FDA’s clearance is based on data from a clinical study comparing the Stelo sensor against other integrated CGM systems.
https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor.
Semaglutide and CVD risk
The FDA has approved semaglutide (Wegovy) injection for the reduction of cardiovascular risk in adults with known heart disease and overweight or obesity. Specifically, the indication is for reduction in risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. This new indication marks a significant milestone as semaglutide becomes the first weight-loss medication also approved to help prevent life-threatening cardiovascular events in this patient population. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist approved for use in patients aged 12 and older with obesity as well as adults with overweight and the presence of at least one weight-related comorbid condition. This week’s approval was based on a comprehensive, placebo-controlled, double-blind trial involving over 17,600 participants. This study demonstrated that semaglutide significantly reduced the risk of major adverse cardiovascular events. The approval was granted to Novo Nordisk.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or
https://www.novo-pi.com/wegovy.pdf
Juvederm Additional Indication
The FDA has approved JUVÉDERM® VOLUMA® XC, a hyaluronic acid (HA) dermal filler, for moderate to severe temple hollowing in adults over the age of 21. This marks the first U.S. FDA approval of a HA dermal filler specifically for use in the temple region, addressing moderate to severe temple hollowing with results that can last up to 13 months with optimal treatment. This is the first HA dermal filler approved for use in the upper face, which is a significant unmet need among patients. Clinical studies have shown that more than 80% of subjects saw at least a one-point improvement in their moderate to severe temple hollowing three months after treatment, with the improvement lasting for more than one year in 73% of cases. Moreover, upwards of 85% of clinical trial participants were satisfied with the balanced, well-proportioned, and symmetric appearance of their face three months post-treatment. The FDA’s approval of JUVÉDERM® VOLUMA® XC was granted to Allergan Aesthetics, an AbbVie company.
https://news.allerganaesthetics.com/News/detail?releasePath=%2F2024%2F3%2Fpr-id-123470
Nivolumab in mUC
The FDA has approved nivolumab (Opdivo) combined with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma. The approval is based on the CHECKMATE-901 trial, showing significant improvements in overall survival and progression-free survival for patients receiving the combination therapy compared to those receiving cisplatin and gemcitabine alone. This is the latest approval for nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody used in various cancers. Nivolumab carries multiple indications including for melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others. The approval was granted to the manufacturer of nivolumab, BMS.
https://packageinserts.bms.com/pi/pi_opdivo.pdf
Zanubrutinib in FL
The FDA has granted accelerated approval to zanubrutinib (Brukinsa) in combination with obinutuzumab (Gazyva) for patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Zanubrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, works by inhibiting BTK, a key molecule in the B cell receptor signaling complex that plays a crucial role in the survival and proliferation of B cells. Obinutuzumab is a type II anti-CD20 monoclonal antibody that targets CD20, a protein expressed on the surface of B cells, thereby inducing cell death. The approval was based on findings from the phase 2 ROSEWOOD trial (NCT03332017), which demonstrated significant improvements in patient outcomes with this combination therapy. Zanubrutinib is manufactured by BeiGene, Ltd, and obinutuzumab is manufactured by Genentech.
https://ir.beigene.com/news/beigene-announces-fda-accelerated-approval-of-brukinsa-for-the-treatment-of-relapsed-or-refractory-follicular/0ae1ffae-3b3c-4df4-99f8-3507c95a352f/
Donanemab and Alzheimer’s
The FDA has postponed its decision regarding the approval of donanemab, an experimental Alzheimer’s treatment developed by Eli Lilly, to a later date. This delay is due to the agency’s plan to convene an unexpected meeting of external advisors to closely examine the safety and efficacy data from a pivotal late-stage trial of donanemab. The exact date for this advisory meeting has not been disclosed by the FDA, indicating that a decision on approval will likely be deferred until after the current month. Originally, the FDA’s decision on whether to approve donanemab was anticipated by the end of the first quarter. However, this timeline represents a postponement from a previously expected approval date last year. The FDA’s call for an advisory meeting underscores the critical and complex nature of approving treatments for Alzheimer’s disease. Eli Lilly has expressed confidence in donanemab’s quote “potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease.”
https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-convene-advisory-committee
Tocilizumab Biosimilar
The FDA has approved Tyenne® (tocilizumab-aazg), a biosimilar referencing Actemra® (tocilizumab), for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. This marks the first tocilizumab biosimilar approved by the FDA with both intravenous (IV) and subcutaneous formulations. Tyenne® is an Interleukin-6 (IL-6) receptor antagonist. The approval of Tyenne® was granted to Fresenius Kabi, headquartered in Germany.
https://www.fresenius-kabi.com/news/tyenne-first-iv-and-subcutaneous-tocilizumab-biosimilar-approved-by-fda
Denosumab Biosimilars
The FDA has approved Jubbonti (denosumab-bbdz) as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) as an interchangeable biosimilar to U.S.-licensed Xgeva (denosumab) for treating certain types of osteoporosis and preventing bone events in cancer patients. This marks the first approval of interchangeable biosimilars for a RANKL inhibitor, where denosumab functions by inhibiting the interaction between RANKL (receptor activator of nuclear factor kappa beta ligand) and its receptor RANK. This inhibition is crucial in preventing osteoclasts, bone cells responsible for breaking down bone, from degrading bone mass in the body. Jubbonti is indicated for various conditions, including osteoporosis in postmenopausal women and men at high risk for fracture, glucocorticoid-induced osteoporosis, and bone mass increase in men receiving androgen deprivation therapy for nonmetastatic prostate cancer. It’s also indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer. Similarly, Wyost is approved for preventing skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treating adults and skeletally mature adolescents with unresectable giant cell tumor of bone, and managing hypercalcemia of malignancy refractory to bisphosphonate therapy. Both Jubbonti and Wyost are to be administered via subcutaneous injection and can be used alongside calcium and vitamin D supplements to prevent or treat low calcium levels. Sandoz is the manufacturer of both Jubbonti and Wyost.
Clobetasol Propionate Eye Drops
The FDA has approved clobetasol propionate 0.05% eye drops for the treatment of post-operative inflammation and pain following eye surgery. This marks the first FDA approval for an ophthalmic formulation of clobetasol propionate and represents the introduction of the first new steroid in the ophthalmic field in over 15 years. Clobetasol propionate is a corticosteroid known for its effectiveness in providing rapid and sustained relief from pain and inflammation. This agent has previously been approved by the FDA in a cream formulation under the brand name Clobex (by Galderma) for treating pruritus in corticosteroid-responsive dermatoses in adults. The eye drops have been developed using Formosa’s proprietary APNT nanoparticle formulation technology, which allows for twice-daily dosing schedule over a 14-day period without the need for tapering. The approval of the clobetasol propionate eye drops was based on the positive results from two pivotal Phase III trials. The FDA’s approval of clobetasol propionate 0.05% eye drops is granted to Eyenovia and Formosa Pharmaceuticals.