- The FDA last week approved Amgen' drug Kyprolis (carflizomib) for use in combination with other oncologic therapies, including deamethasone or lenalidomide, for treatment of relapsed or multiple myeloma.
- Kyprolis also won an expanded indication as a single agent for second-line treatment of the same disease, broadening its November 2012 accelerated approval.
- In addition, Amgen's Repatha (evolocumab) has been approved for treatment of specific types of hypercholesterolemia in Japan—making it the first PCSK9 approved in Japan.
With two approvals in two key markets, Amgen begins 2016 with a strong January. The expansion of the Kyprolis approval is based on a trial demonstrating that combining Kyprolis with dexamethasone doubled time to disease progression compared to Takeda's Velcade. With estimated annual growth of 5.6% in the U.S., Japan, UK, Germany, Italy, and France, Amgen anticipates increased revenues over the next five years.
Repatha is the only PCSK9 inhibitor to be approved in Japan and the only other PSCK9 drug in the hypercholesterolemia space is Sanofi/Regeneron's Praulent. The market for treatment of the high-cholesterol disease is expected to hit $38.5 billion globally by next year.