Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 101 |
| INN | Palivizumab |
| Status | Approved |
| Drug code(s) | MEDI 493 |
| Brand name | Synagis |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | RSV (F glycoprotein) |
| Indications of clinical studies | Prevention of RSV infection In high risk infants |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 10, 1994 |
| Start of Phase 2 | March 15, 1996 |
| Start of Phase 3 | July 15, 1996 |
| Date BLA/NDA submitted to FDA | December 19, 1997 |
| Year of first approval (global) | 1998 |
| Date of first US approval | June 19, 1998 |
| INN, US product name | Palivizumab |
| US or EU approved indications | RSV infection (prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease) |
| Company | AstraZeneca |
| Licensee/Partner | Swedish Orphan Biovitrum, Ilex Oncology |
| Comments about company or candidate | Nov 2018: AstraZeneca announced the company has agreed to sell US rights to Synagis (palivizumab) used for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) to Swedish Orphan Biovitrum (Sobi). Sobi will commercialise Synagis in the US and around 130 AstraZeneca employees will transfer to Sobi as part of the transaction. |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |