23 de agosto de 2019
  • Jueves, 22 de Agosto
  • 22 de julio de 2010

    Kowa Announces Successful EU Regulatory Application for Pitavastatin (1)


    - Pitavastatin safely and effectively reduced LDL-C and achieved European
    Atherosclerosis Society (EAS) guideline targets in the vast majority of
    patients with primary hypercholesterolaemia or combined
    dyslipidaemia, similar to reductions seen with atorvastatin(2)
    and simvastatin(3)
    - Pitavastatin 2 mg and 4mg demonstrated comparable efficacy to commonly
    prescribed statins with 2mg Pitavastatin demonstrating statistically
    significantly superior efficacy compared with simvastatin 20 mg in
    lowering LDL-C, non high-density lipoprotein cholesterol (non-HDL-C) and
    total cholesterol (TC)(3).
    - Pitavastatin effectively reduced LDL-C and improved other parameters of
    lipid metabolism in special patient populations including the
    elderly(4) and patients at higher cardiovascular risk(5)
    - Pitavastatin was superior to pravastatin in improving parameters of
    lipid metabolism in elderly patients (>65 years)(4)
    - Pitavastatin demonstrated a gradual and sustained increase in high
    density lipoprotein cholesterol (HDL-C) over the long-term, supported
    by data from a 52 week extension study(5)

    The overall safety and tolerability of pitavastatin are consistent with other commonly prescribed statins. In pivotal Phase III studies comparing pitavastatin with atorvastatin,(2) simvastatin(3) and pravastatin,(4) the overall safety profile of pitavastatin was demonstrated, with low incidences of adverse events (AEs). All three doses of pitavastatin (1, 2 and 4 mg) demonstrated a comparable safety profile to 10, 20 and 40 mg of pravastatin, (4) which is considered to be the statin least likely to cause ADRs or DDIs. Additionally, pitavastatin has demonstrated a long-term safety profile (to 52 weeks), comparable to that of simvastatin or atorvastatin.(6)

    In two 12-week pivotal Phase III studies of patients with primary hypercholesterolaemia or combined dyslipidaemia, pitavastatin demonstrated a similar tolerability profile to atorvastatin and simvastatin respectively, at comparable therapeutic doses, with most AEs classed mild or moderate.(2,3) Additionally, in a pivotal Phase III trial in the elderly population (>65 years), pitavastatin demonstrated long-term tolerability (52 weeks) with no serious treatment-emergent adverse event (TEAEs) being attributed to pitavastatin as well as pravastatin.

    About pitavastatin

    Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor of HMG-CoA reductase used for primary hypercholesterolaemia and combined dyslipidaemia. Pitavastatin has a unique cyclopropyl group on the base structure common to the statin class. Since its 2003 launch in Japan, pitavastatin has accumulated millions of patient-years of exposure. Many of these patients have comorbidities and are taking multiple medications. Kowa received FDA approval of pitavastatin (LIVALO(R)) for the treatment of primary hypercholesterolaemia and combined dyslipidaemia in August 2009 and it was launched in the U.S. in June 2010. Additionally, Kowa filed in Europe under the decentralized procedure in August 2008. In much of Europe, pitavastatin will be marketed by Recordati. Pitavastatin will be available in three dosage strengths (1 mg, 2 mg and 4 mg).

    Global business in pitavastatin

    Kowa has dedicated itself enthusiastically to the R&D and commercialization of pharmaceutical products including pitavastatin as a global corporation.

    [TAB]

    Country/area Current Launched Distributors

    status (or

    expected)

    Japan Launched September Kowa Pharmaceutical Co. Ltd.

    2003 Daiichi Sankyo Co., Ltd.*1

    Korea Launched July 2005 Choongwae Pharma Corporation

    Thailand Launched January Biopharm Chemicals Co., Ltd.

    2008

    China Launched July 2009 *2

    USA Launched June 2010 *3

    EU Registration 2011 *4

    Canada Submitted 2011 Abbott

    Taiwan Submitted 2011 Tai Tien Pharmaceuticals Co.,

    Ltd. (Mitsubishi Tanabe

    Pharma Co.)

    Indonesia Submitted 2012 Tanabe Indonesia

    (Mitsubishi Tanabe Pharma

    Co.)

    Middle East/ Preparing for 2011 Algorithm SAL

    North Africa submission

    Latin Preparing for 2011 Eli Lilly

    America submission

    Australia/ Preparing for 2012 Abbott

    New Zealand submission

    [FTAB]

    *1. Co-marketing by the two companies under one brand name, Livalo. The annual sales of Livalo tablets in Japan reached 41 billion yen in 2009.

    *2 Kowa (Shanghai) Pharma Consulting. Co., Ltd., a wholly-owned subsidiary of Kowa, is obtaining and providing information to physicians and hospitals in China to ensure proper use of pitavastatin.

    (CONTINUA)


    Country/area Current Launched Distributors
    status (or
    expected)
    Japan Launched September Kowa Pharmaceutical Co. Ltd.
    2003 Daiichi Sankyo Co., Ltd.*1
    Korea Launched July 2005 Choongwae Pharma Corporation
    Thailand Launched January Biopharm Chemicals Co., Ltd.
    2008
    China Launched July 2009 *2
    USA Launched June 2010 *3
    EU Registration 2011 *4
    Canada Submitted 2011 Abbott
    Taiwan Submitted 2011 Tai Tien Pharmaceuticals Co.,
    Ltd. (Mitsubishi Tanabe
    Pharma Co.)
    Indonesia Submitted 2012 Tanabe Indonesia
    (Mitsubishi Tanabe Pharma
    Co.)
    Middle East/ Preparing for 2011 Algorithm SAL
    North Africa submission
    Latin Preparing for 2011 Eli Lilly
    America submission
    Australia/ Preparing for 2012 Abbott
    New Zealand submission

    *1. Co-marketing by the two companies under one brand name, Livalo. The annual sales of Livalo tablets in Japan reached 41 billion yen in 2009.

    *2 Kowa (Shanghai) Pharma Consulting. Co., Ltd., a wholly-owned subsidiary of Kowa, is obtaining and providing information to physicians and hospitals in China to ensure proper use of pitavastatin.

    (CONTINUA)