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Double Approval For Amgen’s Kyprolis and Repatha

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The US Food and Drug Administration (FDA) approved the company’s supplemental New Drug Application (sNDA) for Kyprolis as an injectable to be used in combination with other drugs for the treatment of multiple myeloma.

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January 27, 2016 | by Sarah Massey, M.Sc.

Amgen has started 2016 on a strong note, with two regulatory approvals for the company’s drugs Kyprolis and Repatha. The US Food and Drug Administration (FDA) approved the company’s supplemental New Drug Application (sNDA) for Kyprolis as an injectable to be used in combination with other drugs for the treatment of multiple myeloma.

Multiple myeloma is a cancer of the blood that results in the abnormal development of plasma cells, which prevent the normal generation of blood cells. According to the National Cancer Institute, 27,000 patients were diagnosed with the disease in 2015, and 11,000 patients died as a result.

Kyprolis is to be used in conjunction with dexamethasone or lenalidomide to treat multiple myeloma in patients who have already received one or two other treatments and experienced a relapse. The drug has also been approved in the US as a standalone treatment for the disease.



In addition, Japanese regulators approved Amgen’s Repatha for treatment of hypercholesterolemia – a big win for the company as it is the first PCSK9 drug to be approved in the country. The drug is designated for use in patients who are unresponsive to treatment with statins, and are at a higher risk of cardiovascular issues.

Hypercholesterolemia is a condition in which a patient has dangerously high levels of cholesterol in the blood. The disease can lead to an increased risk of cardiovascular diseases including heart attack and stroke.

Amgen estimates their annual growth to be around 5.6 percent in multiple markets – including the U.S., Japan, UK, Germany, Italy, and France – and expects the new regulatory approval will result in increased revenues over the next five years. In the hypercholesterolemia market, Amgen faces the most competition from AstraZeneca and AbbVie.

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