Takeda Provides Update on Development Status of TAK-475, An Investigational Compound for Treatment of Hypercholesterolemia
OSAKA, Japan, October 29, 2007 --- Takeda Pharmaceutical Company Limited (â€œTakedaâ€) today announced an update of the development status of TAK-475 (r-INNM: lapaquistat acetate), an investigational compound being studied for the treatment of hypercholesterolemia in the U.S., Japan and Europe.
Following the discussions with the Food and Drug Administration (â€œFDAâ€) in the U.S., the FDA has requested additional clinical data prior to submission of a New Drug Application (â€œNDAâ€) for TAK-475, and also it has recommended suspension of the clinical studies with higher doses. This request is stimulated by the observation of an increased frequency of transaminase elevations with the higher dose of TAK-475, including severe cases, compared to that seen in control groups in a pooled analysis of phase 2 and 3 studies completed in the U.S. and Europe. This pattern of ALT elevation has not been observed to date with the lower doses of TAK-475 where frequencies are comparable to control groups.
Conduct of additional clinical studies as requested by the FDA will cause a delay of Takedaâ€™s originally planned US NDA submission target of the first quarter of fiscal 2008. The future development plans for TAK-475 are under discussion with the US FDA. In Europe and Japan where the phase 3 studies and phase 2 studies are being conducted respectively, taking the FDAâ€™s request into consideration, discussions with the relevant regulatory authorities are ongoing regarding the future development and applications for product registration for TAK-475.
Takeda will immediately study the future plans for TAK-475 in the US, Europe and Japan, and such plans will be announced once fixed through discussion with the relevant regulatory authorities.
# # #
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.