MedPath

Palivizumab

Generic Name
Palivizumab
Brand Names
Synagis
Drug Type
Biotech
Chemical Formula
-
CAS Number
188039-54-5
Unique Ingredient Identifier
DQ448MW7KS
Background

Humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human lightchain sequence was derived from the constant domain of Ck and the variable framework regions of the VL gene K104 withJk-4. Palivizumab is expressed from a stable murine (mouse) myeloma cell line (NS0). Palivizumab is composed of to heavy chains (50.6 kDa each) and two light chains (27.6 kDa each), contains 1-2% carbohydrate by weight and has a molecular weight of 147.7 kDa +/- 1 kDa (MALDI-TOF)

Indication

For prophylaxis of respiratory diseases casued by respiratory syncytial virus.

Associated Conditions
Severe Respiratory Syncytial Virus Infection
Associated Therapies
-
pharmaphorum.com
·

FDA advisors back Pfizer's RSV shot for maternal use

An FDA advisory committee unanimously endorsed Pfizer’s RSV vaccine for expectant mothers, citing its effectiveness in preventing severe RSV-related diseases in infants. The vaccine showed 82% efficacy in early trials. Concerns over preterm births were noted, but not statistically significant. Approval could impact the market for RSV antibodies like Beyfortus.
finance.yahoo.com
·

Merck's BLA for RSV Antibody Clesrovimab Gets FDA Acceptance

Merck's BLA for clesrovimab, a monoclonal antibody for RSV prevention in infants, accepted by FDA with a decision expected by June 2025. If approved, available by July 2025. Competing RSV treatments include AstraZeneca and Sanofi's Beyfortus, Pfizer's Abrysvo, and GSK's Arexvy, each targeting different demographics.
biopharmadive.com
·

Merck targets 2025 RSV season with antibody now under FDA review

Merck's clesrovimab, awaiting FDA approval by June 2025, aims to protect newborns from RSV, competing with Sanofi and AstraZeneca's Beyfortus. RSV vaccines for young children are on hold due to safety concerns. Merck's clesrovimab could be available for ordering by July if approved.
biopharmadive.com
·

Merck antibody reduces RSV-related disease, hospitalizations in trial

Merck's experimental antibody drug, clesrovimab, significantly reduced RSV disease incidence by 60% and hospitalizations by 84% in infants, outperforming placebo in a Phase 2b/3 study. If approved, it would compete with Sanofi and AstraZeneca's Beyfortus, the only antibody drug cleared for all infants entering their first RSV season. Merck aims for U.S. approval by the 2025-2026 RSV season.

MSD mulls 2025/26 launch for RSV vaccine after Phase II/III win

MSD plans to launch its RSV vaccine, clesrovimab, by 2025-26 after positive Phase IIb/III trial results showing a 60% reduction in RSV-associated MALRI. Clesrovimab also reduced RSV-associated hospitalizations by 84.2% and LRTD hospitalizations by 90.9% over five months. The vaccine's main competitor, AstraZeneca and Sanofi's Beyfortus, is expected to dominate the market due to its first-to-market advantage.
expresspharma.in
·

AstraZeneca to launch Palivizumab (Synagis) in India

AstraZeneca to launch Palivizumab (Synagis) in India in October 2024, approved by DCGI in September 2023 for RSV prevention in high-risk children: preterm infants, BPD patients, and those with CHD.
© Copyright 2025. All Rights Reserved by MedPath