Monthly Maintenance Dosing Approved for Leqembi
The US Food and Drug Administration (FDA) expanded approval to include a maintenance dosing regimen for Leqembi® (lecanemab-irmb – Eisai and Biogen) on Jan. 26, 2025. The first anti-amyloid monoclonal antibody to receive standard FDA approval for treating Alzheimer’s disease, Leqembi was initially approved to be administered at a dose of 10mg/kg once every two weeks by intravenous (IV) infusion. Labeling now indicates that a transition to a maintenance dosing regimen of 10mg/kg every four weeks may be considered after 18 months of every two weeks initiation phase. Updated prescribing information can be found here.
Enhertu Receives Extended Approval
On Jan. 27, 2025, the FDA approved another indication for Enhertu® (fam-trastuzumab deruxtecan-nxki – AstraZeneca and Daiichi Sankyo) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-low (Immunohistochemistry (IHC)1+ or IHC2+) or HER2-ultralow (IHC0 with membrane staining) breast cancer as determined by an FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting. Enhertu is a conjugate that links an antibody specific to HER2 with a topoisomerase inhibitor that kills cancer cells that was initially approved in 2022. The phase III trial, DESTINY-Breast06, showed a 36% reduction in the risk of disease progression or death when compared to chemotherapy (p<0.0001) with a superior median progression free survival of 13.2 months compared to 8.1 months with chemotherapy. For treating breast cancer, the recommended dose is 5.4mg/kg infused IV once every three weeks until the cancer stops responding to the drug or the side effects become unbearable for the patient. No new safety concerns were identified and because it may cause potentially fatal lung conditions and it also may damage a developing baby, Enhertu has boxed warnings and a patient Medication Guide. Enhertu also has approval for treating several additional indications. Complete prescribing information may be found here.
Ozempic Approved for Chronic Kidney Disease
The FDA approved Ozempic® (semaglutide – Novo Nordisk) to reduce the risk of kidney disease worsening, kidney failure and death due to cardiovascular disease in adults with type two diabetes and chronic kidney disease (CKD) on Jan. 28, 2025. Initially approved in 2017, Ozempic is indicated along with diet and exercise to treat adults who have type 2 diabetes. An additional approval to decrease the chances of heart attack, strokes, other adverse cardiovascular (CV) events and death for adults who have both type 2 diabetes and CV disease was FDA approved in January 2020. A glucagon-like peptide-1 (GLP-1) analog injected once a week, Ozempic lowers blood glucose levels through several pathways, including slowing glucose absorption after meals, decreasing glucagon production and promoting insulin secretion from the pancreas. About 40% of people with type two diabetes also have CKD, about 37 million Americans. The phase III trial showed that when added to standard of care, Ozempic 1mg demonstrated a superior 24% risk reduction of kidney disease worsening, kidney failure and death due to cardiovascular disease compared to placebo. Recommended dosing for new patients begins at 0.25mg once a week for four weeks and then increases to 0.5mg for at least four weeks. If blood sugar control is still inadequate, doses can be raised to 1mg for four weeks or longer, and then to 2mg, if necessary. Here is the updated prescribing information.
Symbravo Approved for Migraine
On Jan. 30, 2025, the FDA approved Axsome Therapeutic’s Symbravo® (meloxicam/rizatriptan) for the acute treatment of migraine with or without aura in adults. Symbravo is an oral, fixed-dose combination of meloxicam, a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) that inhibits the synthesis of prostaglandins, and rizatriptan, a 5-HT1B/D agonist that inhibits calcitonin gene-related peptide (CGRP)–mediated vasodilation, using MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology. MoSEIC is designed to improve meloxicam absorption allowing it to be absorbed five times faster while maintaining a long half-life in the blood. The rapid absorption allows meloxicam to be used for acute treatment of migraine. Phase III studies showed a statistically significant improvement in a greater percentage of patients achieving pain freedom two hours after dosing, which was sustained through 48 hours for many patients. When compared to rizatriptan alone, studies showed a single dose of Symbravo was superior for sustained pain freedom from two to 24 hours and 77% of participants did not need rescue medication. Symbravo was well tolerated with somnolence and dizziness being the most common adverse effect in less than 5% of participants. Recommended dosing is one tablet by mouth as needed containing meloxicam 20mg and rizatriptan 10mg. Axsome expects a May 2025 launch. Full prescribing information may be found here.
Third Actemra Biosimilar Approved
The FDA approved Avtozma® (tocilizumab-anoh – Celltrion) as the third biosimilar to Actemra® (tocilizumab – Genentech). Avtozma is indicated for treating active, moderate to severe cases of rheumatoid arthritis (RA) and giant cell arteritis in adults, and active cases of polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) in patients who are as young as two years old and coronavirus disease (COVID-19). It can be used alone or combined with other anti-inflammatory drugs, such as methotrexate. It has a boxed warning because using any tocilizumab drug may increase the risk of opportunistic bacterial, fungal, viral or other infections. Before tocilizumab is started and during treatment with it, patients should be tested for tuberculosis (TB). Like Actemra, Avtozma will be available in vials for IV infusions and in single-dose prefilled syringes and autoinjector for subcutaneous (SC) use. Tofidence® (tocilizumab-bavi – Biogen), the first Actemra biosimilar that was approved in 2023, is available only as an IV form and Tyenne® (tocilizumab-aazg – Fresnius Kabi), the second approved in 2024, is available in both IV and SC form. Complete prescribing information will be available on the Drugs@FDA drug database at www.fda.gov.
New Indication Pipeline for GLP1/GIPs Issues Document
Glucagon-like peptide 1 (GLP-1) receptor agonists and glucose-dependent insulinotropic polypeptide (GIP) dual agonists are being studied in a variety of indications outside of diabetes and weight management. Most recently, Zepbound® (tirzepatide – Eli Lilly) received approval for adults with obesity and obstructive sleep apnea. This document is intended to review the new indications in the pipeline and what indications may be studied next. Please see attached.