Japan's Astellas Pharma has filed with Japan's Pharmaceutical and Medical Devices Agency for approval of PCSK9 inhibitor evolocumab for high cholesterol under the Amgen ($AMGN) Astellas BioPharma joint venture.
The move comes days after Astellas filed an application to seek an additional indication for Kiklin to nondialysis patients based on two Phase III studies in Japan.
Kiklin is currently indicated for the treatment of hyperphosphatemia in patients on dialysis with chronic kidney disease. The drug was discovered by Ilypsa, now a wholly owned subsidiary of U.S. biotech Amgen.
In April 2006, Astellas obtained exclusive development and marketing rights for Kiklin for the treatment of hyperphosphatemia in Japan.
The evolocumab filing follows a Phase III study and marks a first local class filing for the strategic partnership.
- here are the releases from Astellas on Evolocumab (PDF) and Kiklin