For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Corporate Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/
Daiichi Sankyo Launches Methemoglobinemia Treatment Methylene Blue Injection 50mg
TOKYO, Japan (March 20, 2015) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the launch in Japan of the methemoglobin treatment, Methylene Blue Injection 50mg (JAN: Methylthioninium Chloride Hydrate; approval for manufacturing and marketing obtained December 26, 2014; drug price standard listing February 24, 2015).
Toxic methemoglobinemia is a toxic disorder in which the methemoglobin concentration in the blood is elevated due to various substances found in drugs, pesticides, etc., causing symptoms such as cyanosis, headache, dizziness, shortness of breath, and loss of consciousness.
Methylene Blue is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs*1, set up by the Ministry of Health, Labour and Welfare (MHLW). Daiichi Sankyo acquired sole development and marketing rights for Japan from PROVEPHARM SAS before developing Methylene Blue, and received a grant from the Pharmaceutical Development Support Center for its development.
As part of its CSR effort, Daiichi Sankyo is committed to making unapproved and off-label drugs available to patients who are waiting for them to be approved.
*1 Working group under MHLW that aims to accelerate the development process for drugs not yet approved in Japan but which have been available in Europe and the U.S.
Product Overview
Launch date: March 20, 2015
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Product name
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Methylene Blue Injection 50 mg “Daiichi Sankyo”
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Generic name (JAN)
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Methylthioninium Chloride Hydrate
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Price Listing
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50mg 10mL 1 tube: 120,382 yen; Drug price standard listing date: February 24, 2015
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Indication
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Toxic methemoglobinemia
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Dosage and administration
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For infants older than 3 months, children and adults, administer 1-2 mg/kg of Methylthioninium Chloride Hydrate once intravenously for at least 5 minutes. If symptoms fail to show improvement within 1 hour, the same dosage may be administered again as necessary, up to an accumulated maximum dosage of 7 mg/kg.
For infants younger than 3 months, administer 0.3-0.5 mg/kg of Methylthioninium Chloride Hydrate once intravenously for at least 5 minutes. If symptoms fail to show improvement within 1 hour, the same dosage may be administered again as necessary.
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Approval date
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December 26, 2014
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Manufacturing
and marketing
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Daiichi Sankyo Company, Limited
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