【求助】发（（很多金币））求一个新药的信息？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 . 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/ 2010 Note: 17th wave, STA Prescribing Outlook: Available only to registered users Trial or other data Jul 10: in its draft guidance on mifamurtide, NICE has recommended against its use in combination with postoperative multi-agent chemotherapy in children, adolescents & young adults for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′s 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 查看更多
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