Amgen's Repatha cleared as first PCSK9 inhibitor in Japan for treatment of high cholesterol

Amgen announced on Friday that the PCSK9 inhibitor Repatha (evolocumab) has been authorised by the Japanese Ministry of Health, Labour and Welfare for the treatment of high cholesterol. The therapy, which was developed in the country by a joint venture between Amgen and Astellas, is specifically indicated for use in patients with familial hypercholesterolaemia or hypercholesterolaemia who carry a high risk of cardiovascular events who failed to adequately respond to statin therapy. Amgen R&D chief Sean Harper remarked "today's approval of Repatha, the first PCSK9 inhibitor approved in Japan, is an important milestone for patients and physicians who need additional treatment options to lower LDL cholesterol."

Amgen noted that the approval was supported by data from Phase III studies illustrating the efficacy and safety of the drug in addition to background lipid-lowering therapy that included statins. In the YUKAWA-2 trial of Japanese subjects with high cardiovascular risk and high cholesterol, Repatha in combination with Pfizer's Lipitor (atorvastatin) was associated with reductions in LDL-C of 67 percent to 76 percent at week 12 versus placebo. Meanwhile, in the TAUSSIG study, Repatha was found to lower LDL-C by approximately 23 percent.

Repatha became the first PCSK9 inhibitor to receive clearance anywhere in the world following its approval by the European Commission in July last year. The therapy was approved for use in adults with heterozygous familial hypercholesterolaemia, homozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease who require additional reductions in LDL-C in the US the following month. The therapy has also been authorised for the treatment of high cholesterol in Canada.

For recent analysis about the PCSK9 market, see Physician Views Poll Results: Taking an early look at the competing anti-PCSK9 mAb launches.

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