Dec. 18, 2007
Announcement of the Launch of
the Pulmonary Arterial Hypertension Agent Careload® LA Tablets 60μg in Japan
Japan December 18, 2007 - Toray Industries Inc. (“Toray”; Headquarters: Tokyo, President and CEO: Sadayuki Sakakibara) and Astellas Pharma Inc. (“Astellas”; Headquarters: Tokyo; President and CEO: Masafumi Nogimori) today announced that they will launch the oral PGI2 derivative prolonged release, Careload® LA Tablets 60μg (generic name: beraprost sodium) on December 19, 2007, with the indication of “pulmonary arterial hypertension (PAH)”.
Careload® LA Tablets 60μg is the prolonged release formulation of beraprost sodium, which is a PGI2 derivative, discovered by Toray. Toray has submitted an application for beraprost sodium with indication of PAH based on the results of domestic clinical trials subjecting primary pulmonary hypertension and pulmonary hypertension following collagenosis in September 2006. It has been designated for a priority review by Ministry of Health, Labour and Welfare. On October 19, 2007, Toray has obtained a marketing approval for Careload® LA Tablets 60μg with the indication of PAH, and it will be launched on December 19, 2007.
- About PAH
- PAH is that peripheral arteriole lumen of pulmonary artery where blood pumped from heart to lung gets narrow, and it makes difficult for blood to flow. This causes pulmonary artery high pressure. PAH is classified in two types, one is primary pulmonary hypertension (PPH), and the other is secondary pulmonary hypertension following specific diseases. Exertional dyspnea, fatigability and palpitation are commonly observed initial symptoms, and once it advances, heart failure may result.
- About Careload® LA Tablets 60μg
- Careload® LA Tablets 60μg is the world first oral PGI2 derivative prolonged release and expected to provide a new therapeutic choice, an oral agent which can be widely used, to patients suffering from PAH.
Toray had obtained marketing approval for beraprost sodium tablets to be indicated for improvement of ulcer, pain and feeling cold associated with chronic arterial occlusion
in January 1992, primary pulmonary hypertension in September 1999, and it has already been available in Japanese market as Dorner® Tablets 20μg by Astellas since April 1992. Careload® LA Tablets 60μg will be marketed by Astellas as well as Dorner® Tablets 20μg.
Details of Careload® LA Tablets 60μg are as follows:
| Date of Marketing approval | : | October 19, 2007 |
| Brand name | : | Careload® LA Tablets 60μg |
| Generic name | : | beraprost sodium |
| Indication | : | pulmonary arterial hypertension (PAH) |
| Dosage and administration | : | The usual dosage for adults should be started at 120μg of beraprost sodium daily, administered orally in 2 divided doses after breakfast and supper, and gradually increased while carefully monitoring the patient’s symptoms (adverse reactions). The dosage may be adjusted according to the patient’s symptoms and tolerability up to 360μg daily administered orally in 2 divided doses after breakfast and supper. |
| Approval holder | : | Toray Industries Inc. |
| Packaging | : | Tablet 60μg: 100tablets (PTP) |
| NHI reimbursement prices | : | 243.30 Japanese yen/60μg tablet |
| Date of NHI price listed | : | December 14, 2007 |
| Date of launch | : | December 19, 2007 |
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