For Immediate Release

2016.08.26

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, Executive Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com

Daiichi Sankyo Receives Additional Dosage Regimen Approval in Japan for Long-acting Neuraminidase Inhibitor Inavir® Dry Powder Inhaler 20mg

Tokyo, Japan (August 26, 2016) - Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has received additional dosage regimen approval in Japan for influenza A and B antiviral agent, Inavir Dry Powder Inhaler 20mg (JAN: Laninamivir Octanoate Hydrate) for the prevention of influenza, in single inhalation doses of 40 mg for adults and children 10 years of age or older, and single inhalation doses of 20 mg for children younger than 10 years of age.

Inavir is a long-acting neuraminidase inhibitor developed by Daiichi Sankyo for the prevention and treatment of influenza A and B. These additional dosage regimen approvals make it possible to administer single inhalation doses of this drug to adults and children for the prevention of influenza virus infection.

The additional dosage regimen approvals of this influenza antiviral agent will allow Daiichi Sankyo to offer a new choice of medicines to all patients and medical personnel, allowing Daiichi Sankyo to further contribute to the health of society.

Product overview

Drug name

Inavir Dry Powder Inhaler 20mg

Date of approval for partial changes

August 26, 2016

Indications and usage

Treatment and prevention of influenza A and B viruses

Dosage and administration

(additional approval underlined)

1. For the treatment of influenza virus

Adults: A single inhaled dose of 40 mg of laninamivir octanoate.

Children: If less than 10 years old, a single inhaled dose of 20 mg of laninamivir octanoate.

If 10 years old or older, a single inhaled dose of 40 mg of laninamivir octanoate.

2. For the prevention of influenza virus

Adults: A single inhaled dose of 40 mg of laninamivir octanoate. Alternatively, daily single inhaled dosage of 20 mg of laninamivir octanoate for two days as well.

Children: If less than 10 years old,a single inhaled dose of 20 mg of laninamivir octanoate.

If 10 years old or older,a single inhaled dose of 40 mg of laninamivir octanoate. Alternatively, daily single inhaled dosage of 20 mg of laninamivir octanoate for two days as well.

Daiichi Sankyo Co. Ltd. published this content on 26 August 2016 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 26 August 2016 07:34:03 UTC.

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