- For Print
- June 15, 2007
Ajinomoto Co., Inc.
Eisai Co., Ltd.
Ajinomoto Co., Inc. (“Ajinomoto”, President and CEO: Norio Yamaguchi, Headquarters: Tokyo) and Eisai Co., Ltd. (“Eisai”, President and CEO: Haruo Naito, Headquarters: Tokyo) launched today a once-weekly antiosteoporotic agent “Actonel® 17.5 mg tablets” (generic name: risedronate sodium hydrate), which was included in the NHI price list on June 8, 2007.
Ajinomoto owns the drug manufacturing approval of above product, and Eisai distributes the product supplied by Ajinomoto.
In Japan, a once-daily formulation of risedronate sodium hydrate “Actonel® 2.5 mg tablets” has been available in the market since May 2002 and has contributed to the treatment of a great number of osteoporosis patients.
The newly launched “Actonel® 17.5 mg tablets” requires only once-weekly dosing and is expected to improve patients' quality of life with the enhanced convenience in medication. Also, “Actonel® 17.5 mg tablets” was confirmed as safe and effective as the once-daily formulation “Actonel® 2.5 mg tablets” in the phase Ⅲ double-blind comparative studies conducted in Japan.
Risedronate sodium hydrate is a bisphosphonate antiosteoporotic agent, which was originally synthesized by Norwich Eaton Pharmaceuticals, Inc. in the United States (then a subsidiary of The Procter & Gamble Company and now Procter & Gamble Pharmaceuticals, Inc.). This agent has two distinctive features from other antiosteoporotics:
In additional analyses of large clinical trials, vertebral and non-vertebral
fracture suppressing effects of this agent showed statistically significant difference as compared to placebo as early as 6 months after starting administration.In large clinical trials with the primary endpoint of the reduction of frequency
of hip fractures, this agent showed statistically significant difference as compared to placebo.
Ajinomoto and Eisai are committed to treatment of osteoporosis patients in Japan and increasing benefits to them through marketing “Actonel® tablets”.
[The following is a product outline and photograph of “Actonel® 17.5mg tablets” for reference.]
Contact
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Ajinomoto Co., Inc.
Pharmaceutical Alliance Dept.
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Eisai Co., Ltd.
Corporate Communications Dept.
Reference
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| Product outline of “Actonel® 17.5 mg tablets” | |
|---|---|
| ‹ Brand Name › | “Actonel® 17.5 mg tablets” |
| ‹ Generic Name › | Risedronate sodium hydrate |
| ‹ Indication › | Osteoporosis |
‹ Dosage and Administration › The usual dosage in adults is 17.5 mg of risedronate sodium to be taken orally once a week on awakening with an adequate amount of water (about 180 mL). Patients should not lie down at least for 30 minutes after taking the medication and avoid eating, drinking except for water and taking any other oral drugs. |
|
| ‹ Date of NDA approval › | April 18, 2007 |
| ‹ NHI price › | ¥846.60- per tablet |
| ‹ Date of launch › | June 15, 2007 |
