Drugs / Motavizumab
Motavizumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | respiratory syncytial virus infectious disease | 2010-08-30 | “received a second complete response letter (CRL) on motavizumab from the US Food and Drug Administration (FDA)” astrazeneca.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00192504 | Mar 2004 → Jan 2005 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT00192465 | Nov 2003 → Apr 2004 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00113490 | May 2005 → Feb 2006 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT00435227 | Mar 2007 → May 2008 | respiratory syncytial virus infectious disease | MedImmune LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00316264 | Apr 2006 → Feb 2007 | lung disorder, respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00538785 | Oct 2005 → Jun 2008 | congenital heart disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT00628303 | Oct 2010 → Feb 2011 | asthma | MedImmune LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00129766 | Nov 2004 → May 2006 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | Met primary |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT00421304 | Jan 2007 → Sep 2009 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT00192478 Comparator | Feb 2004 → May 2006 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 3 | NCT00121108 Comparator | Nov 2004 → Dec 2010 | — | MedImmune LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2010-12-21 | AstraZeneca | Regulatory AstraZeneca discontinues development of motavizumab for RSV prophylaxis indication astrazeneca.com ↗
The Company has requested withdrawal of the Biological License Application (BLA) pending at the US Food and Drug Administration (FDA). |
| 2010-08-30 | AstraZeneca | Regulatory MedImmune receives complete response letter on motavizumab astrazeneca.com ↗
AstraZeneca today announced that MedImmune, its biologics unit, has received a second complete response letter (CRL) on motavizumab from the US Food and Drug Administration (FDA). |
| 2010-06-25 | AstraZeneca | Regulatory FDA Resets its Decision Date For Motavizumab astrazeneca.com ↗
AstraZeneca today announced that MedImmune, its wholly owned biologics unit, received notice that the U.S. Food and Drug Administration (FDA) has reset the decision date for its review of motavizumab to 27 August 2010. |
| 2010-06-02 | AstraZeneca | Regulatory FDA Advisory Committee Reviews MedImmune’s Motavizumab astrazeneca.com ↗
MedImmune, AstraZeneca’s biologics unit, today announced that the US Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee has voted 14 to 3 to recommend that motavizumab should not be licensed for marketing regarding the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants. |
| 2009-12-24 | AstraZeneca | Regulatory MedImmune Replies to FDA Complete Response Letter on Motavizumab astrazeneca.com ↗
AstraZeneca today announced that MedImmune, its biologics unit, has filed its formal regulatory reply to a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-12-21 | AstraZeneca | AstraZeneca discontinues development of motavizumab for RSV prophylaxis indication astrazeneca.com ↗ |
| 2010-08-30 | AstraZeneca | MedImmune receives complete response letter on motavizumab astrazeneca.com ↗ |
| 2010-06-25 | AstraZeneca | FDA Resets its Decision Date For Motavizumab astrazeneca.com ↗ |
| 2010-06-02 | AstraZeneca | FDA Advisory Committee Reviews MedImmune’s Motavizumab astrazeneca.com ↗ |
| 2010-05-28 | AstraZeneca | NOTICE: Advisory Committee Briefing Materials for Motavizumab BLA Available on US FDA Web Site astrazeneca.com ↗ |
| 2009-12-24 | AstraZeneca | MedImmune Replies to FDA Complete Response Letter on Motavizumab astrazeneca.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | motavizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00129766 ↗ |
| Known as | MEDI-524 | “The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).” NCT00192504 ↗4“Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season” NCT00316264 ↗ “MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV)” NCT00192478 ↗ |
| Known as | Numax | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743042 ↗ |
| Known as | Numax-TM | “MEDI-524 (Numax-TM)” NCT00192465 ↗ |
| Modality | Monoclonal antibody | “a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV)” NCT00113490 ↗ |
| Route | Intramuscular | “Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.” NCT00113490 ↗ |