Products include Nirsevimab-alip, Remdesivir, Inclisiran, and Lecanemab-irmb.
The FDA has approved nirsevimab-alip (Beyfortus), a monoclonal antibody with activity against respiratory syncytial virus (RSV) associated with lower respiratory tract disease in neonates and infants born during or entering the first RSV season. A single dose of nirsevimab-alip administered as an intramuscular injection prior to or during RSV season may provide protection from the virus. Three clinical trials supported the safety and efficacy of nirsevimab-alip and evaluated medically attended RSV lower respiratory tract infection 150 days after administration. Potential adverse effects include rash and infection site reactions.
FOR MORE INFORMATION: astrazeneca.com
From: Gilead Sciences, Inc
The FDA has approved remdesivir (Veklury) to treat patients with COVID-19 who are facing severe renal impairment, including those on dialysis. Remdesivir is a nucleotide analogue that directly inhibits viral replication inside the cell by targeting the SARS-CoV-2 viral RNA polymerase. This is the first treatment to be approved for patients across all stages of renal disease, according to Gilead. The updated prescribing information does not require dose adjustments for patients who are rentally impaired and removed the requirements for estimated glomerular filtration rate testing before or during treatment with remdesivir. The REDPINE study (NCT04745351) evaluated the efficacy and safety of remdesivir in patients with severely reduced kidney function who were hospitalized with COVID-19.
FOR MORE INFORMATION: gilead.com
The FDA has approved an expanded label for inclisiran (Leqvio) to treat elevated low-density lipoprotein cholesterol (LDL-C) in patients with comorbidities, such as hypertension and diabetes, and who have yet to experience a cardiovascular event. Inclisiran is a small interfering ribonucleic acid originally approved in December 2021 for patients who are on a maximally tolerated dose of statins and need additional LDL-C reduction. Inclisiran is supplied in a single-dose prefilled syringe and is administered as 2 doses a year, following 2 initial doses. This has been shown to lower LDL-C by up to 52% among patients with heart disease or with an increased risk of heart disease who were unable to reach their LDL-C target on statin therapy.
FOR MORE INFORMATION: novartis.com
From: Eisai Inc and Biogen Inc
The FDA converted the accelerated approval of lecanemab-irmb (Leqembi) to a full traditional approval to treat Alzheimer disease (AD) in patients with mild cognitive impairment or mild dementia state of disease. Lecanemab-irmb is the first amyloid β–directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of AD. In the CLARITY AD clinical trial (NCT03887455), individuals with mild cognitive impairment or mild dementia state of disease received the approved dose of lecanemab-irmb, 10 mg/kg every 2 weeks. Adverse events reported included brain swelling and bleeding, nausea, vomiting, and changes in blood pressure.
FOR MORE INFORMATION: biogen.com; us.eisai.com