Press Releases / Notices

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NEWS 2009

December 11, 2009 Pharmaceuticals

Launch of once-daily-available "adcirca® Tablets 20mg" for the treatment of pulmonary arterial hypertension

Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa) has launched today once-daily-available phosphodiesterase-5 (PDE-5) inhibitor “adcirca® Tablets 20mg” (generic name: tadalafil) for the treatment of pulmonary arterial hypertension.

  Pulmonary arterial hypertension (PAH) is a refractory disease with elevated peripheral pulmonary arterial pressure caused by insufficient blood flow through narrowed lumen of peripheral pulmonary smaller arteries which carry blood from heart to lung, which is accompanied by the symptoms such as shortness of breath and fatigue and results in heart failure when advanced.

  The patient population is very small estimated at around 6,000 to 9,000 in Japan. Approximately 70% of adult patients is female.

  “adcirca® Tablets 20mg” is a pharmaceutical product developed by Eli Lilly and is administered orally 40mg , with two of 20mg tablet, once daily in PAH patients.
  Eli Lilly submitted new drug application (NDA) of this product in US, EU and Japan in 2008. In the global randomized double-blind clinical trial in which Japanese patients were included as subjects, its efficacy and safety were confirmed. This product was approved in US in May, Japan in October, and EU in November 2009.

This product has an inhibitory activity against PDE-5 which largely distributes in smooth muscle of pulmonary artery, and maintains high cGMP level in pulmonary artery smooth muscle cells. As a result, endogenous nitric oxide enhances vasodilatation of pulmonary arteries, and pulmonary hemodynamics expect to be improved in PAH patients.
Since an efficacy with once-daily administration is expected due to long-lasting effective blood concentration and no food effect, this product is a new oral remedy for PAH which can improve patient compliance. In addition, because the mechanism of action of this product is different from those of other existing treatments for PAH such as beraprost and bosentan hydrate, a possibility of combination therapy between “adcirca® Tablets 20mg” and them in PAH patients is expected in Japan.

By the launch of “adcirca® Tablets 20mg”, Nippon Shinyaku expects to contribute to the treatment of PAH patients and improvement of their QOL.

Brand name:adcirca® Tablets 20mg
Marketed by:Nippon Shinyaku Co., Ltd.
Marketing authorization holder:Eli Lilly Japan K.K.
Approval number:22100AMX02266000
Composition:20mg of tadalafil is contained in a tablet
Generic name:Tadalafil
Indication:Pulmonary arterial hypertension
Dosage and administration:Generally, 40mg of tadalafil is orally administered once daily
Approval date:October 16, 2009
NHI price listing date:December 11, 2009
NHI price:1,769.7Yen / tablet
Package:PTP 100 tablets (PTP 10 tablets × 10)