Santen to Lift Condition for Approval of PAPILOCK Mini Ophthalmic Solution 0.1%
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February 25, 2008, Osaka, Japan-Santen Pharmaceutical Co., Ltd. have announced that the conditions for the approval of vernal keratoconjunctivitis*1 treatment PAPILOCK Mini ophthalmic solution 0.1% (generic name: ciclosporin) has been lifted. This was reported by the First Committee on New Drugs, the Pharmaceutical Affairs and Food Sanitation Council, the Ministry of Health, and Labor & Welfare on February 22, 2008.
PAPILOCK Mini ophthalmic solution 0.1% was designated as an orphan drug for vernal keratoconjunctivitis treatment*2. As the number of clinical trial cases is limited, post-marketing surveillance for all-patient was required as the condition for approval. This has been made effective until data on a certain number of patients is gathered.
The decision to lift the condition for approval has been accepted, taking the following into consideration:
| 1) |
Safety and efficacy were confirmed with more than 1,000 cases completed 6-month follow-up of all-patient surveillance. |
| 2) |
The measures listed below will be ensured after lifting the condition for approval in order to assure proper usage. |
| 3) |
One year follow-up drug use investigation will be newly conducted to gather further safety and efficacy data as well as data concerning the conditions of administration. Due to the lifting of the condition for approval, patient registration for the current ongoing all-patient post-marketing surveillance will be terminated on February 29, 2008. |
Santen places utmost priority for the safety of patients and will continuously gather and convey information for proper use of PAPILOCK Mini even after the condition for approval is lifted.
Measures
- Use under ophthalmologists who are familiar with the treatment of vernal keratoconjunctivitis, in principle.
- -Use only for vernal keratoconjunctivitis (in patients whose symptoms cannot be adequately controlled by anti-allergy drugs). [Note: safety and efficacy have not been established for patients with conditions other than vernal keratoconjunctivitis or for mild cases of vernal keratoconjunctivitis which can be treated with anti-allergy drugs]
- -Contraindication for patients who have a history of hypersensitivity for the ingredients of PAPILOCK mini, and have an ocular infection.
- -May cause infection or exacerbation of an infection. Careful use is required especially in concomitant use of other drugs that have immunodepressive effects.
- -Careful observation is necessary when administrating for a long period. Patients should not continue administration indefinitely without consulting with their ophthalmologist.
| Brand name: |
PAPILOCK Mini ophthalmic solution 0.1% |
| Generic name: |
Ciclosporin |
| Indication: |
Vernal keratoconjunctivitis (in patients whose symptoms cannot be adequately controlled by anti-allergy drugs) |
| Dosage: |
Usually 1 drop/time, 3 times/day |
| Features: |
- Suppresses the generation of cytokine*3 from T cells which control immune responses such as allergies
- Significant improvement of giant papillae on tarsal conjunctiva*4, the predominant symptom of vernal keratoconjunctivitis
- Preservative-free, unit-dose preparation
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Glossary
| 1. |
Vernal keratoconjunctivitis: A persistent ocular disease with severe allergic conditions, observed mainly within patients under 20 years old. Anti-allergy drugs are usually used in its treatment, however, it is estimated that there are approximately 4,000 vernal leratoconjunctivitis patients in Japan of whom have existing anti-allergy drugs are not effective. |
| 2. |
Orphan drug: A drug with little commercial potential, despite a high degree of medical need, because the number of patients is very small. Orphan drug R&D is eligible for government subsidization in Japan. |
| 3. |
Cytokine: Hormone-like protein secreted by various kinds of cells that control the extent and length of the immune response and mediate the exchange of information between cells. |
| 4. |
Giant papillae on tarsal conjunctiva: One of the typical symptoms of vernal keratokonjunctivitis, characterized by stonewall-like bumps (papillae) that appear on the inner side of the eyelid (tarsal conjunctiva). Giant papillae are categorized by those of which are sized larger than 1mm. |
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