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Systematic (IUPAC) name
2-[(N-{(2R)-[(2-acetamido-2,3-dideoxy-D-glucopyranos-3-yl)oxy]-propanoyl}-L-alanyl-D-isoglutaminyl-L-alanyl)amino]ethyl (2R)-2,3-bis(hexadecanoyloxy)propyl hydrogen phosphate

Identifiers

CAS number        
£¨1£©83461-56-7
£¨2£©838853-48-8 (mifamurtide sodium ¡¤ xH2O)

Chemical data

Formula         C59H109N6O19P
Mol. mass         1237.499 g/mol
SMILES         eMolecules & PubChem

Pharmacokinetic data

Bioavailability         N/A
Half-life         minutes (in plasma)
18 hrs (terminal)

Therapeutic considerations

Licence data         EMA:Link
Pregnancy cat.         not investigated
Legal status         ℞ Prescription only
Routes         intravenous liposomal infusion over one hour

muramylNAc-Ala-isoGln-Lys-tripeptide-PE

Pharmacological Action

Adjuvants, Immunologic [Link to MeSH] - Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The ... [show more]

Adjuvants, Immunologic [Link to MeSH] - Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The classical agents (Freund's adjuvant, BCG, Corynebacterium parvum, et al.) contain bacterial antigens. Some are endogenous (e.g., histamine, interferon, transfer factor, tuftsin, interleukin-1). Their mode of action is either non-specific, resulting in increased immune responsiveness to a wide variety of antigens, or antigen-specific, i.e., affecting a restricted type of immune response to a narrow group of antigens. The therapeutic efficacy of many biological response modifiers is related to their antigen-specific immunoadjuvanticity. [show less]

Immunologic Factors [Link to MeSH] - Biologically active substances whose activities affect or play a role in the functioning of the immune system.

  Pharmacological Classification
Chemical Actions and Uses [Link to MeSH]
      Pharmacologic Actions [Link to MeSH]
            Physiological Effects of Drugs [Link to MeSH]
                  Immunologic Factors [Link to MeSH]
                        Adjuvants, Immunologic [Link to MeSH]
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¿ÉÒԲο¼Ò»ÏÂwiki°Ù¿Æ
http://en.wikipedia.org/wiki/Mifamurtide
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Information
Generic Name: mifamurtide   
Trade Name: Mepact (EU), Junovan (US)  
Synonym: MTP-PE, muramyl tripeptide phosphatidylethanol  
Entry Type: New chemical entity  

Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: Liposomal formulation of muramyl tripeptide phosphatidylethanolamine   
Epidemiology: Osteosarcoma is a rare disease, with about 1,200 new cases in Europe each year (12). 2-3% of all childhood cancers are osteosarcoma with survival at 60-65% (11)   
Indication: Osteosarcoma  
Additional Details: non-metastatic, resectable  

Developmental Status
UK: Launched  
EU: Launched  
US: Pre-registration (Filed)  
UK launch Plans: Available only to registered users
Actual UK launch date: 01/02/2010  

Method(s) of Administration   
Intravenous  

Comments
Feb 10: Launched in EU [13].
06/02/2010 16:58:41  
Jun 09: Takeda have taken over the originator company (May 09). EU launch delayed until 2010 (personal communication).
19/06/2009 12:15:04  
Mar 09: Company plan to submit an amended NDA to FDA mid-2009 after receiving a non-approvable letter, requesting more data, in Aug 08 (10)
09/03/2009 19:35:10  
Mar 09: Licensed in EU (10)
09/03/2009 19:21:55  
EU CHMP positive opinion for the treatment of patients with non-metastatic, resectable osteosarcoma, Nov 08. Recommendation to be adopted in Dec 08, with final approval 60-90days later. (9)
21/11/2008 09:35:23  
CHMP opinion expected Q3 08, final decision anticipated Q4 08 (8)
09/04/2008 12:45:47  
Confirmed plans to file in EU and expect to receive approval in 2007(1). Orphan drug status in EU and US (1). Plans to file in US in 06 (2). Filed in US Oct 06 (3). The FDA and the EMEA have designated Orphan Drug status to Junovan (3). Filed in EU Nov 06 (4). Negative opinion from FDA advisory committee May 07 (5). Non-approvable letter from FDA - more data required Aug 08 (6).
28/02/2008 09:51:04  
Confirmed plans to file in EU and expect to receive approval in 2007(1). Orphan drug status in EU and US (1). Plans to file in US in 06 (2). Filed in US Oct 06 (3). The FDA and the EMEA have designated Orphan Drug status to Junovan (3). Filed in EU Nov 06 (4). Negative opinion from FDA advisory committee May 07 (5). Non-approvable letter from FDA - more data required Aug 08 (6).


Company Information
Name: Takeda  
US Name: IDM Pharma  
  
NICE Information
In timetable: Yes   
When: Nov / 2010  
Note: 17th wave, STA  
   
   
Prescribing
Outlook: Available only to registered users

Trial or other data
Jul 10: in its draft guidance on mifamurtide, NICE has recommended against its use in combination with postoperative multi-agent chemotherapy in children, adolescents & young adults for treating high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection (14).
13/07/2010 09:49:30
Mar09: EU approval based on the Phase 3 MEPACT trial (INT-0133), a National Cancer Institute funded cooperative group study conducted by the Children¡äs Oncology Group and the largest study ever completed in osteosarcoma, enrolling approximately 800 patients. The study evaluated patient outcomes with the addition of mifamurtide to three- or four-drug adjuvant chemotherapy (cisplatin, doxorubicin, and methotrexate with or without ifosfamide). Results demonstrated that mifamurtide resulted in approximately a 30% decrease in the risk of death with 78% of patients surviving after six years of follow-up.(10)
09/03/2009 19:25:29
Filed in US for use in the treatment of newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy. IDM requested that the FDA consider granting priority review status, which could shorten review time from the standard ten months to six months if granted. The FDA customarily accepts or refuses to file NDAs and designates review status within 60 days of filing(3).  


Evidence Based Evaluations
SMC  http://www.scottishmedicines.org/smc/7718.html
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