Bayer's CTEPH Treatment Adempas Granted Approval In Japan
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted approval for Bayer HealthCare’s drug Adempas. The company has already secured an orphan drug designation indication for the drug from the MHLW in September of 2011.
Adempas (riociguat) is used to treat adult patients with inoperable chronic-thromboembolic pulmonary hypertension (CTEPH) as well as persistent/recurrent CTEPH after surgical operations. Possible curative treatment options include complex surgical procedures such as pulmonary endaterectomy. However, a significant number of CTEPH patients are not good candidates for surgery and the disease is known to recur even after operations. Bayer plans to offer Adempas as a potential alternative for these CTEPH patients.
Kemal Malik, head of Bayer Global Development and member of the Bayer Executive Committee, said, “Riociguat achieves meaningful clinical improvements, which is a much needed step forward for patients whose CTEPH is inoperable or whose disease is persistent or recurrent.” Malik said riociguat’s approval is the first approved treatment for the life-threatening disease.
Adempas’ approval is based on data from randomized global Phase III study CHEST-1. The study was placebo-controlled and double-blind. Interim results from long term CHEST-2 study extensions were also basis for the MHLW approval. Patients treated with riociguat under the CHEST-1 trial showed improvement against the baseline using the six minute walk test. In the CHEST-2 trial, patients achieved significant changes in exercise capacity after 16 weeks.
Adempas also exhibited improvements across several relevant secondary endpoints such as cardiopulmonary hemodynamics. The drug was well tolerated in general and maintained a good safety profile in WHO Functional Class and disease-related biomarkers.
Bayer said Phase III of the CHEST trial program is underway with the long term CHEST-2 extension study. The company has already secured approval for Adempas in the US, Canada, and Swirtzerland. Bayer is currently seeking regulatory approval in the EU.
Source:
http://finance.yahoo.com/news/bayer-receives-approval-adempas-first-105900339.html