Preliminary U.S. Registration Strategy For Investigational Drug, Hematide™ / Peginesatide, To Treat Anemia In Chronic Renal Failure

Aug 6th, 2010 | By healthnews | Category: Health

Main Category: Urology / Nephrology
Article Date: 06 Aug 2010 – 8:00 PDT

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Affymax, Inc. and Takeda Pharmaceutical Company Limited announced that the companies have decided on a preliminary strategic path forward for the investigational drug, Hematide™/peginesatide, for the treatment of anemia in chronic renal failure patients in the United States.

Affymax and Takeda are continuing to conduct further analysis of the PEARL and EMERALD studies which evaluated the efficacy and safety of Hematide in chronic renal failure patients with anemia.

Before year end, the companies plan to discuss with the FDA the U.S. registration strategy for Hematide. Subject to feedback from the FDA, the plan is to pursue a New Drug Application (NDA) for treatment of anemia in dialysis patients, while continuing to evaluate the non-dialysis indication. The timeline for possible submission of the NDA will be aimed for first half of 2011, but will be finalized after the FDA meeting.

Results of Phase 3 Program

As previously announced, the primary efficacy endpoint, the mean change in hemoglobin (Hb) from baseline, in each of the four Phase 3 studies (EMERALD 1, EMERALD 2, PEARL 1 and PEARL 2) met the statistical criteria for non-inferiority, when Hematide was compared to epoetin and darbepoetin, in correcting and/or maintaining Hb in the target range. Hematide also met the statistical criterion for non-inferiority in the combined four studies for the adjudicated cardiovascular composite safety endpoint (CSE), which was composed of death, stroke, myocardial infarction, congestive heart failure, unstable angina, and arrhythmia (hazard ratio (HR) 1.06, 90 percent confidence interval (CI) 0.91 – 1.22). The median duration of follow-up for patients on study drug in the four trials was 1.3 years.

In a subgroup analysis of CSE events in the EMERALD studies in maintenance treatment of anemia in dialysis patients, the frequency of CSE events was balanced between Hematide and the comparator (HR 0.95, 90 percent CI 0.79 – 1.13).

A difference in CSE events was noted, however, when a subgroup analysis was conducted in non-dialysis patients. In the PEARL trials, which evaluated correction and maintenance treatment of anemia in non-dialysis patients, the frequency of CSE events was higher in the Hematide group (21.6 percent) versus the comparator (17.1 percent) (HR 1.34, 90 percent CI 1.03 – 1.73).

The Hematide Phase 3 program, which involved 2,609 randomized patients, consisted of four open-label, randomized active-controlled clinical trials in the U.S. and Europe, including two studies in non-dialysis patients (PEARL 1 and 2) and two others in dialysis patients (EMERALD 1 and 2). In all studies, Hematide was dosed once every four weeks while comparator drugs were dosed more frequently according to their product labels. In these studies, epoetin was dosed one-to three-times per week and darbepoetin was dosed every two weeks. The Hb target range was 11-12 g/dL for non-dialysis patients and 10-12 g/dL for those on dialysis.

About Hematide

Hematide is a novel investigational synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA.

Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials investigated the potential for Hematide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized outside the United States (in the European Union and Japan) by Takeda.

Source: Takeda



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