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In contrast to the chorused complains against the - as lobbyists put it - “glacier speed” of new drug approval in Japan, the chronology of Alimta shows quite the opposite. Let’s follow:

• In June 2005, it became clear that in addition to factory workers, many people living near the former factory operated by machinery maker Kubota Corp. in Hyogo Prefecture, had developed asbestos-related disorders, including malignant pleural mesothelioma. Soon similar health problems were reported in other areas such as Gifu and Nara prefectures. According to the statistics released by the Ministry of Health, Labor and Welfare, 7,924 people across the nation died of mesothelioma in the 11 years since 1995. Due to the difference in collecting the primary data in different prefecture, the actual number patients is thought to be higher and not expected to peak until 2030
• In the second half of 2005, the asbestos became a household word after an extensive coverage by the media. A package of bills aimed at providing financial support to people suffering from asbestos-linked diseases was enforced in 2006. According to the compensation scheme, the Government plans to collect 7.4 billion Yen within 4-year period starting 2007 to cover the compensation including treatment for victims and the affected families
• In November 2005, the Health, Labor and Welfare Ministry has decided to shorten the review period for a new drug to treat mesothelioma (Alimta) to one year form the average time of two years. Meanwhile, Nippon Eli Lily Japan KK has been conducting dose-finding trial from February and late Phase II trial from October 2005
• A submission for approval of Alimta in Japan was made on June 26, 2006 for treatment of malignant pleural mesothelioma in combination with cisplatin. On June 28, 2006 six manufacturers of cisplatin products applied for revision of “Indications” in the Package Inserts of theirs respective 6 products (in 10 formulations). The approval review was completed by December 7, 2006 and the Minister of Health, Labor and Welfare granted on January 4, 2007 a Manufacturing & Sale Approval to Alimta (vials 500 mg) along the revised cisplatins. Overall, the review took only 5 months
• In another speedy leg, Alimta has been given a reimbursement price on January 19 and the company is planning to start the sales on January 22, 2007. Due to the limited pre-approval trials, as one condition for approval, the maker is obliged to recruit at lest 300 patients in Phase IV study. The drug will be initially introduced at around 400 hospitals nationwide specialized in chemotherapy

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