Astellas gets OK to resume U.S. anaemia drug trial
TOKYO, April 3 (Reuters) - Japan's Astellas Pharma Inc (4503.T) said it had received permission from U.S. health authorities to resume trials of an anaemia drug that were halted after the death of a patient.
The phase II trial of the drug YM 311 or FG-2216 for patients with pre-dialysis chronic kidney disease had been on hold since May. The trials are being conducted by partner U.S. biotech firm FibroGen Inc.
The patient who died from severe liver inflammation was aged 76 and had been taking 10 other medicines besides YM 311.
Until the trial was halted, the drug had been positioned as one of three experimental medicines that Astellas was giving its highest development priority.
"We will continue to seek FDA advice at appropriate intervals as we continue development," the Japanese drug maker said in a statement issued on Wednesday.
Astellas first obtained the Japan rights to YM 311 in 2004. In 2006 it obtained rights to jointly develop the drug as well as another related anaemia drug, FG-4592, in Europe, the CIS and the Middle East, in a deal worth $765 million.
Astellas also received permission to resume trials of FG-4952, had also been halted due to problems with YM 311. (Reporting by Edwina Gibbs)
