Shionogi and InterMune have announced the marketing approval of pirfenidone (Pirespa) for the treatment of idiopathic pulmonary fibrosis (IPF) in Japan, making it the first approved therapy for IPF in a major market. Shionogi developed pirfenidone in Japan and has rights in Japan, Taiwan and South Korea, and InterMune is currently conducting a Phase III programme known as CAPACITY to support approval in other markets.

IPF is characterized by worsening pulmonary function, dyspnoea and cough. The precise aetiology of IPF is unknown, but lung injury and excessive pulmonary deposition of fibrotic tissue have a key role in disease pathogenesis. There are presently no drugs approved specifically for IPF by the FDA or the EMEA, and standard therapy based on corticosteroids and immunosuppressants has shown only very limited benefit in reducing disease progression in patients with IPF.

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