From Alzheimer's treatments to novel pain management solutions, January brought advances across multiple therapeutic areas. Here is a comprehensive overview of the month's key FDA decisions.
Neurology & Pain Management
FDA Approves SYMBRAVO for Acute Migraine
The FDA approved SYMBRAVO® (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. The MOMENTUM trial demonstrated superior pain relief versus placebo at 2 hours, with sustained benefit for up to 48 hours. Common adverse effects included somnolence and dizziness. SYMBRAVO is contraindicated in patients with cardiovascular disease, a history of stroke, or uncontrolled hypertension. Availability is expected within 4 months.
First-in-Class Non-Opioid Pain Therapy Receives Approval
Journavx (suzetrigine, formerly VX-548), a NaV1.8 inhibitor, has been approved for moderate-to-severe acute pain. Phase 3 trials showed superior pain reduction compared to placebo. Common adverse reactions included itching, muscle spasms, elevated creatine phosphokinase, rash, nausea, headache, and dizziness. The medication is contraindicated with strong CYP3A inhibitors and grapefruit products. The launch is expected later this year.
New Maintenance Dosing Regimen Approved for Leqembi
Leqembi (lecanemab-irmb) received approval for a 1-every-4-weeks maintenance dose following an 18-month biweekly initiation phase in early Alzheimer's disease. Three-year clinical data showed more than twofold reduction in cognitive decline versus placebo. Key safety considerations include brain swelling and amyloid-related imaging abnormalities. The treatment is currently approved in U.S., Japan, and China.
Esketamine Monotherapy Approved for Treatment-Resistant Depression
Esketamine (Spravato) gained approval as a monotherapy for treatment-resistant depression, with 22.5% of patients achieving remission at 4 weeks compared to 7.6% with placebo. The treatment is available only through SPRAVATO REMS program due to sedation and dissociation risks. It is approved in 77 countries with over 140,000 patients treated worldwide.
Diagnostics & Testing
Breakthrough Status for Alzheimer's Blood Test
The Access p-Tau217/β-Amyloid 1-42 plasma ratio test received Breakthrough Device Designation for Alzheimer's diagnosis. This non-invasive blood test aims to detect Alzheimer's pathology earlier, improving diagnosis and monitoring capabilities. Further clinical validation is ongoing.
Oncology
Enhertu Expands to HR-Positive, HER2-Low Breast Cancer
Enhertu (fam-trastuzumab deruxtecan-nxki) received approval for HR-positive, HER2-low, and HER2-ultralow metastatic breast cancer following endocrine therapy progression. DESTINY-Breast06 trial showed an improved median progression-free survival of 13.2 months versus 8.1 months for chemotherapy. This approval extends HER2-targeted therapy to 85% to 90% of HR-positive, HER2-negative metastatic breast cancers.
KRAS-Targeted Combination Approved for Colorectal Cancer
The FDA approved sotorasib (Lumakras) with panitumumab (Vectibix) for KRAS G12C-mutated metastatic colorectal cancer post-chemotherapy. The combination improved median progression-free survival to 5.6 months versus 2 months for standard care. Common side effects include rash, dry skin, diarrhea, stomatitis, and fatigue. The therascreen KRAS RGQ PCR Kit was approved as a companion diagnostic.
Datroway Approved for Advanced Breast Cancer
Datopotamab deruxtecan-dlnk (Datroway) received approval for HR-positive, HER2-negative metastatic breast cancer after prior chemotherapy. Clinical trials showed improved progression-free survival of 6.9 months versus 4.9 months for chemotherapy. The therapy is dministered as an intravenous infusion every 3 weeks.
Endocrinology & Metabolic Disease
Semaglutide Indication Expanded for CKD in Type 2 Diabetes
Semaglutide (Ozempic) received approval to slow kidney disease progression, reduce end-stage kidney disease risk, and lower cardiovascular mortality in adults with type 2 diabetes and chronic kidney disease. The FLOW trial demonstrated a 24% risk reduction in kidney disease progression and cardiovascular mortality compared to placebo.
Multiple Sclerosis
Boxed Warning Added to Glatiramer Acetate
The FDA added a Boxed Warning to glatiramer acetate (Copaxone, Glatopa) due to anaphylaxis risk. Between 1996 and 2024, 82 confirmed cases were reported, including 51 hospitalizations and 6 fatalities. Permanent discontinuation is recommended if anaphylaxis occurs.
Tobacco Control
First Nicotine Pouch Authorization
The FDA authorized 20 ZYN nicotine pouches, marking the first authorization in this category. Clinical data showed lower harmful constituents compared to cigarettes. Marketing restrictions include television ad bans and age requirements for promotional models. Youth use remains low at 1.8% in 2024 surveys.