For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Sunao Manabe, Representative Director, President and COO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Junichi Onuma,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
https://www.daiichisankyo.com
Daiichi Sankyo Launches “Tarlige® Tablets” for Pain Treatment in Japan
Tokyo, Japan (April 15, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the launch of Tarlige® Tablets 2.5 mg, 5 mg, 10 mg, 15 mg (generic name: mirogabalin besilate; hereafter, the drug) for the treatment of pain in Japan.
This drug, an α2δ ligand*1 , created by Daiichi Sankyo, was approved for marketing in Japan in January 2019 on the basis of the results of phase 3 clinical trials conducted in Asia including Japan in patients with diabetic peripheral neuropathic pain (DPNP) *2 and postherpetic neuralgia (PHN) *3, for the indication of peripheral neuropathic pain (PNP) *4.
Daiichi Sankyo expects the drug to benefit patients in Japan by providing a new therapeutic option for the treatment of peripheral neuropathic pain.
Product Outline
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Brand name
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Tarlige® Tablets 2.5 mg, 5 mg, 10 mg, 15 mg
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Generic name
(JAN)
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mirogabalin besilate
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Indication
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Peripheral neuropathic pain
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Dosage and administration
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Normally, the initial dose for adults is 5 mg of mirogabalin given orally twice daily, and then the dose is gradually increased by 5 mg at an interval of at least a week to 15 mg, given orally twice daily. A dose may be adjusted appropriately between 10 mg and 15 mg depending on ages and symptoms, given twice daily.
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Drug price
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Tarlige® Tablets 2.5 mg: 78.00 yen/tablet
Tarlige® Tablets 5 mg: 107.70 yen/tablet
Tarlige® Tablets 10 mg: 148.70 yen/tablet
Tarlige® Tablets 15 mg: 179.60 yen/tablet
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Date of approval
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January 8, 2019
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Date of listing in the NHI price
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February 26, 2019
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Date of launch
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April 15, 2019
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Manufacture and Marketing
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Daiichi Sankyo Company, Limited
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*1: α2δ (Alpha 2 delta) ligand
α2δ ligand binds to the α2δ subunits of voltage-dependent calcium channels.
*2: Diabetic peripheralneuropathic pain (DPNP)
DPNP is a typical example of PNP caused by nerve damage. Diabetic peripheral neuropathy is a disorder that causes neuropathy and numbness to the extremities and is one of the most common long-term 3 major complications of diabetes. Its symptoms include severe pain, hyperalgesia, numbness, impairment of equilibrium and muscle movements, burning pain and pricking pain. Pain is often exacerbated during the night and may cause sleep disorders. Of the diabetic population estimated to exceed 10 million in Japan, 9- 22% of the patients are reported to suffer DPNP.
*3: Postherpetic neuralgia (PHN)
PHN is a typical example of PNP caused by nerve damage. Onset of herpes zoster is caused by a decline of immunity against varicella-zoster virus which established latent infection in ganglia. In PHN, burning pain or pain shooting through the body like electricity persists even after cure of herpes zoster. It is regarded as one of the intractable pains, which cause muscle weakness and paralysis in rare cases. PHN is reported to affect 10-25% of the 500-600 thousand Japanese who develop herpes zoster annually.
*4: Peripheralneuropathicpain (PNP)
PNP is caused by damage or functional abnormality of peripheral nerves due to various causes. Typical PNPs are diabetic PNP (DPNP)*2 and postherpetic neuralgia (PHN) *3.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com.