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The table below is a review of notable updates that occurred in January 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.
| Drug | Pharmacologic Class | Proposed Indication | Status |
| Cardiovascular Disease | |||
| Olezarsen (Ionis Pharmaceuticals, Inc.) | ApoC-III inhibitor | Treatment of familial chylomicronemia syndrome. | Fast Track designation |
| Tecarfarin (Cadrenal Therapeutics) | Vitamin K antagonist | Prevention of systemic thromboembolism of cardiac origin in patients with end-stage renal disease and atrial fibrillation. | Fast Track designation |
| Gastrohepatic Disorders | |||
| Obeticholic acid (Intercept Pharmaceuticals) | Farnesoid X receptor agonist | Treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis. | Resubmitted NDA accepted for review |
| Vonoprazan (Phathom Pharmaceuticals) | Oral small molecule potassium-competitive acid blocker | Treatment of erosive esophagitis. | FDA’s decision delayed for NDA |
| Hematological Disorders | |||
| Avapritinib (Blueprint Medicines) | Tyrosine kinase inhibitor | Treatment of indolent systemic mastocytosis in adults. | sNDA accepted for Priority Review |
| Immunization | |||
| Prevnar 20 (Pfizer) | 20-valent pneumococcal conjugate vaccine | Prevention of invasive pneumococcal disease in infants and children 6 weeks through 17 years of age, and prevention of otitis media caused by 7 of the 20 serotypes. | sBLA accepted for Priority Review |
| Musculoskeletal Disorders | |||
| AOC 1020 (Avidity Biosciences) | Monoclonal antibody that binds to the transferrin receptor 1 conjugated with siRNA targeting DUX4 mRNA. | Treatment of facioscapulohumeral muscular dystrophy. | Fast Track designation |
| Vamorolone (Santhera and ReveraGen) | Dissociative steroidal drug | Treatment of Duchenne muscular dystrophy. | NDA accepted for filing |
| Neurologic Disorders | |||
| Donanemab (Eli Lily and Company) | Antibody therapy that targets a modified form of deposited amyloid-beta peptide called N3pG | Treatment of patients with early symptomatic Alzheimer disease. | Complete Response Letter issued |
| Rozanolixizumab (UCB) | Humanized monoclonal antibody that binds with high affinity to human neonatal Fc receptor | Treatment of adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. | BLA accepted for Priority Review |
| Poisoning and Drug Dependence | |||
| OPNT003 (nasal nalmefene; Opiant Pharmaceuticals) | Opioid antagonist | Treatment of opioid overdose. | NDA accepted for Priority Review |
| Psychiatric Disorders | |||
| Gepirone HCI extended-release (Exxua; Fabre-Kramer Pharmaceuticals) | Serotonin 1A receptor agonist | Treatment of major depressive disorder. | Resubmitted NDA accepted for review |
| Brexpiprazole (Otsuka and Lundbeck) | Atypical antipsychotic | Treatment of agitation associated with Alzheimer dementia. | sNDA accepted for Priority Review |
| Urological Disorders | |||
| Empagliflozin (Eli Lily and Company) | Sodium-glucose co-transporter 2 inhibitor | To reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease. | sNDA accepted for review |
