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Rockwell Medical, Inc. (Wixom, MI) announced that the United States has approved commercial sales of Dialysate Triferic.

The company is developing multiple formulations of Triferic for treating anemia in adult hemodialysis patients. Dialysate Triferic is the first formulation to be sold. Rockwell expects to file a New Drug Application (NDA) with the FDA for its next formulation, I.V. Triferic, within the second quarter of 2019, the company said in a media release.

Rockwell received a preliminary recommendation from the Centers for Medicare & Medicaid Services (CMS) on April 26, 2019. Receipt of final approval would result in a unique J-code for the powder packet formulation of Dialysate Triferic (J-codes are created and used for non-orally administered medications and chemotherapy drugs; the code would be J1444).

“Dialysate Triferic is an innovative physiological alternative to existing IV iron formulations,” said Marcos Rothstein, MD, professor of medicine in the Division of Nephrology at Washington University School of Medicine. He said the new product does not increase iron stores and has no ties to any cases of anaphylaxis. “Additionally, in patients with reticuloendothelial (RE) block, it overcomes functional iron deficiency,” Rothstein said.

Fibrogen, based in San Francisco, has announced results from a safety analysis of its Roxadustat Global Phase 3 program and data reports focused on major adverse cardiovascular events. The phase 3 trials were conducted by FibroGen, as well as partners Astellas Pharma (Tokyo) and AstraZeneca (Cambridge, UK) to learn more about its ability to treat anemia in CKD patients. Patients who participated fell into three groups: non-dialysis dependent (NDD), patients new to dialysis, and dialysis-dependent (DD) CKD populations. In dialysis patients, roxadustat was compared with Epogen (epoetin alfa). For predialysis patients, the study drug was compared with a placebo.

The pooled findings from the global trials showed that roxadustat in some instances did not perform better than the comparison drug/placebo in the area of cardiac event data. Only in the “incident dialysis” (new to dialysis) group was the study drug “superior” to epoetin alfa in the results for “time to first Major Adverse Cardiac Events (MACE), plus heart failure requiring hospitalization and unstable angina requiring hospitalization” (MACE+), according to a media release.

FierceBiotech noted that “After talking to management at FibroGen to unpack ‘a very complex dataset,’ analysts at Jefferies think the readout is far better than investors feared initially and ultimately a positive for the biotech company and its partners, AstraZeneca and Astellas.” Jeffries is an investment banking firm.

The European Medicines Agency (EMA) noted that the primary safety assessment should be for the MACE+ category before approval. For a planned NDA submission to the FDA, one of the key safety endpoints is MACE.