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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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Web site to offer information on drug side effects

 

The Pharmaceutical and Medical Devices Agency on Tuesday launched a Web site that enables people to search for lists of side effects, symptoms and associated diseases brought on by a variety of medicines. The site, www.info.pmda.go.jp, includes a database of all side effects as reported by drug manufacturers. The first data to be made public by the agency was in April 2004, with accounts detailing 732 medicinal products and 2,477 related case studies that include information such as age, gender, disease, details of the side effects, the drug and other medicines taken concurrently. The site also includes case studies for the 63 people whose deaths during that period were brought on by side effects from medicines they were taking. Twelve of these deaths were linked to the lung cancer drug gefitinib, marketed as Iressa. Warnings also are included for cases in which the side effects were found to not be connected to health problems. The PMDA will make information from May 2004 onward available in due course, aiming to put a system into effect before the end of March 2008, with updates every six months. Until now, such reports were limited to cases involving previously unknown side effects, or where revisions had been made to warnings over usage. The new system was conceived of in the face of increasing complaints from citizens’ groups and others organizations demanding all the information be made public, as only 1,872 of the 25,000 or so drug-related side effects last fiscal year had been disclosed. The agency, an independent organization, has also begun posting on its Web site easy-to-understand explanations on dosage and side effects. Beginning with 54 kinds of drugs, including oral diabetes medication, the next medicines to be posted will include antirheumatic and antiasthmatic drugs. (The Daily Yomiuri, February 9, 2006, p. 3)

Femara - an aromatase inhibitor - is known to be submitted and currently under a review by the Japanese regulatory authorities. Yet, as distributed today by the mass media, the warnings issued by Novartis AG were forwarded to the physicians in Japan as well. As read between the lines - under the provision of the Pharmaceutical Affairs Law (PAL), any unapproved drug could be imported for individual use in Japan as long as the custom official is shown a prescription by Japanese doctor. Obviously, Femara (the name is misspelled in the original news release below) - another of the unapproved anti-cancer drugs in Japan has been imported by significant number of female patients treated domestically.

One of the unapproved anti-cancer products, recommended so far by the Committee for the Examination of the Use of Unapproved Medicinal Products for domestic development is thalidomide, which was once registered and in 1962 withdrawn in Japan. The task for clinical development with a sole indication for treatment of multiple myeloma is being undertaken by the Fujimoto Seiyaku KK. The Osaka-based company is small, discloses its staff (about 300), but not the revenues. Apparently, it is run in a very traditional way, so one may wonder how it will survive the PR barrage while developing the notorious compound. On July 20, 2005 in what it seemed as a rare press conference the Fujimoto’s management reported the progress in planning the clinical trials: IRBs of 22 hospitals accepted the protocol and the recruitment of patients through informed consent has started. However, the trials are amidst of a considerable controversy. While for years the Japanese branch of International Myeloma Foundation (IFM Japan) has lobbied for official registration (in contrary to private use legal import), the relatives of the 60s disaster victims are voicing strong concerns regarding the safety. Surprisingly or not, no references of any kind about thalidomide on the web site of Fujimoto have been posted.

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Technorati Tags: MHLW; Japanese regulatory affairs