Main Category: Urology / Nephrology
Also Included In: Blood / Hematology
Article Date: 07 Dec 2011 - 22:00 PST
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An FDA Advisory Committee has voted in favour of approving peginesatide for use with dialysis patients who developed anemia caused by CKD (chronic kidney disease). The Oncologic Drugs Advisory Committee (ODAC) voted 15 in favor, 1 against, with 1 abstention. Peginesatide is an ESA (synthetic erythropoiesis-stimulating agent). The Panel (Advisory Committee) wrote that peginesatide was shown to have a favorable benefit/risk profile.
President and CEO of Affymax, John Orwin, said:
"We're encouraged by the panel's positive view of the benefit/risk profile of peginesatide in the dialysis setting. Anemia 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 anemia in patients living with this condition."
The Advisory Panel is just that, a Committee that advises the FDA to help it when considering approving new drugs and therapies. The FDA is not bound by anything it says. However, in most cases, the FDA goes along with the Committee's recommendations. Affymax submitted an NDA (New Drug Application) in May 2011. A final decision is expected towards the end of the first quarter of 2012.
Azmi Nabulsi, MD, president, Takeda Global Research & Development Center, Inc., said:
"Today's ODAC vote represents an important step in the peginesatide New Drug Application review process. As we heard from the discussion today, limited therapeutic options are available for the treatment of anemia 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."
Affymax says it is hosting a teleconference and live audio webcast at 8am (Eastern Time) on Thursday, 8th December, when it will discuss the Advisory Panel's recommendation. You can access this by: Telephone from within the USA - (866) 393-1565Telephone from outside the USA - +1 (973) 409-9608Online here (replays available for 30 days)Peginesatide, formerly known as Hematide, is a synthetic PEGylated peptic compound which binds to and stimulates the erythropoietin receptor, and consequently acts as a synthetic erythropoiesis-stimulating agent (ESA).
According to Affymax Inc.:
"The peginesatide Phase 3 clinical program was the largest to support the new drug application of an ESA in the treatment of anemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events."
Affymax discovered the compound, which is currently being developed by Affymax and Takeda.
If the FDA approves peginesatide, which seems much more likely now, it will probably be the first once-monthly anemia medication in chronic kidney disease for dialysis patients available in America, Affymax informs.
Written by Christian Nordqvist
Copyright: Medical News Today
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MLA
8 Dec. 2011.
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