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January 17, 2014
| Torii Pharmaceutical Co., Ltd. |
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| Torii announces the New Drug Application Approval for "CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen" a Sublingual Immunotherapy Drug for Japanese cedar Pollinosis, in Japan |
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Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced today that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application for "CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen" ("CEDARTOLEN" hereinafter), a sublingual immunotherapy drug for Japanese cedar pollinosis.
CEDARTOLEN, which is the first sublingual immunotherapy drug approved in Japan, can be administered at home and can relieve patients from the pain associated with subcutaneous injection, compared to subcutaneous immunotherapy that has been performed in the past.
In the Phase III clinical study in patients with Japanese cedar pollinosis in Japan, the CEDARTOLEN was statistically superior to placebo, in lowering the "overall nasal symptom and medication score" at the end of treatment (primary efficacy endpoint).
Torii expects that CEDARTOLEN will make a contribution as a new option for treating Japanese cedar pollinosis. The timing of the launch of this drug will be announced following the National Health Insurance price listing.
| Outlines of the approval |
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Product Name: |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 200 JAU/mL bottle |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL bottle |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL pack |
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Indications: |
Japanese cedar pollinosis (Allergen immunotherapy) |
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Dosage and Administration: |
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| 1. Period of updosing (1st - 2nd weeks) |
For adults and children over 12 years of age, the following doses will be administered sublingually once daily for 2 weeks after the initiation of administration. The solution should be retained for 2 minutes, and then swallowed. Gargling, eating, and drinking should be avoided for the next 5 minutes.
| 1st week of updosing |
2nd week of updosing |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 200 JAU/mL bottle |
CEDARTOLEN® SUBLINGUAL DROP
- Japanese Cedar Pollen 2,000 JAU/mL bottle |
| Day 1 |
0.2mL |
Day 1 |
0.2mL |
| Day 2 |
0.2mL |
Day 2 |
0.2mL |
| Day 3 |
0.4mL |
Day 3 |
0.4mL |
| Day 4 |
0.4mL |
Day 4 |
0.4mL |
| Day 5 |
0.6mL |
Day 5 |
0.6mL |
| Day 6 |
0.8mL |
Day 6 |
0.8mL |
| Day 7 |
1mL |
Day 7 |
1mL |
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| 2. Period of maintenance (3rd week and thereafter) |
| In the period of maintenance following the completion of the period of gradual increase, the full dose of CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen 2,000 JAU/mL pack (1 mL) will be administered sublingually once daily. The solution should be retained for 2 minutes, and then swallowed. Gargling, eating, and drinking should be avoided for the next 5 minutes. |
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Approval conditions: |
Necessary measures should be taken for manufacturing and marketing so that this drug will be prescribed and used only by physicians with adequate knowledge and experience regarding sublingual immunotherapy, will be used only under the supervision of physicians and medical institutions that can manage and explain the risks, etc. of this drug, and will be dispensed at pharmacies only after the pertinent physicians and medical institutions have been confirmed.
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| About Japanese cedar pollinosis |
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Japanese cedar pollinosis collectively refers to an allergic disease caused by Japanese cedar pollen. Patients with Japanese cedar pollinosis primarily have allergic rhinitis and allergic conjunctivitis. Patients develop sneezing and nasal discharge immediately after Japanese cedar pollens enter their nose, and have nasal occlusion after a while. Also, when Japanese cedar pollens enter their eyes, they have itchy, runny and bloodshot eyes. When the symptoms are strong, antigen components of pollens not absorbed in the nose may flow from the nose to the throat, causing itchiness of the throat and coughing. Further, symptoms such as headache due to nasal occlusion, slight fever due to inflammatory reactions in the nose and the throat, and dullness may occur.
According to a nationwide survey, it is estimated that about 20% of Japanese people have pollinosis and that about 70% of those have Japanese cedar pollinosis.
(A FY 2010 MHLW-subsidized research program for prophylaxis/treatment of immunological allergic diseases, "Research for Correct Treatment of Pollinosis") |
| About allergen immunotherapy |
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| Allergen immunotherapy is a therapeutic method that the causative allergen of an allergic disease is administered at a low concentration/dose at first and is increased gradually in order to attenuate hypersensitivity to the allergen. |
| About development of therapeutic medicine for Japanese cedar pollinosis |
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| Torii has been conducting a Phase I clinical study of the sublingual immunotherapy drug "TO-206" (tablet) for Japanese cedar pollinosis, and conducting research for the development of Japanese cedar pollinosis vaccines in collaboration with RIKEN, independent administrative agency. |
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