A biopharmaceutical company, Affymax, Inc. and Takeda Pharmaceutical
Company Limited reported that the US Food and Drug Administration (FDA)
Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with 1
abstention, that peginesatide demonstrated a favourable benefit/risk
profile for use in the treatment of dialysis patients with anaemia due
to chronic kidney disease (CKD).
Peginesatide is a synthetic
PEGylated peptidic compound that binds to and stimulates the
erythropoietin receptor and thus acts as an ESA. The peginesatide phase 3
clinical programme was the largest to support the new drug application
of an ESA in the treatment of anaemia in CKD and the first to
prospectively evaluate the cardiovascular safety of an ESA via an
analysis of independently adjudicated cardiovascular events. The
compound was discovered by Affymax and is being co-developed by Affymax
and Takeda. If approved, peginesatide may be the first once-monthly
product for anaemia in CKD for dialysis patients available in the United
States.
"We're encouraged by the panel's positive view of the
benefit/risk profile of peginesatide in the dialysis setting," said John
Orwin, president and CEO of Affymax. "Anaemia affects many patients in
the dialysis setting, and we look forward to working with the FDA as
they complete their evaluation of peginesatide. As a once-monthly
treatment, peginesatide, if approved, has the potential to be an
important option in the management of anaemia in patients living with
this condition."
While the FDA is not bound by the
recommendations of its advisory committees, their guidance will be
considered by the FDA in its review of the New Drug Application (NDA)
that was submitted for peginesatide in May 2011. The scheduled
Prescription Drug User Fee Act (PDUFA) date for peginesatide is March
27, 2012.
"Today's ODAC vote represents an important step in the
peginesatide New Drug Application review process," said Azmi Nabulsi,
MD, president, Takeda Global Research & Development Center, Inc. "As
we heard from the discussion today, limited therapeutic options are
available for the treatment of anaemia in dialysis patients with chronic
kidney disease. Affymax and Takeda will continue efforts to make this
alternative available to dialysis patients and the providers who treat
them."
