The FDA has approved Rockwell Medical Inc.’s intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate), for treating adult hemodialysis patients who need iron replaced and their hemoglobin maintained.

Triferic AVNU now takes its place next to Triferic dialysate as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adults with hemodialysis-dependent chronic kidney disease.

The approval comes a day before its PDUFA date of March 28. Triferic was developed under a special protocol assessment agreed upon with the FDA.

The I.V. formulation works via dialysate during each dialysis treatment. Triferic AVNU can be administered directly by I.V. no matter what mode of bicarbonate delivery a dialysis center might use. Many dialysis centers in international markets now use dry bicarbonate bags or cartridges and on-line generation, which Rockwell said is incompatible with Triferic Dialysate. The method is increasingly in use in the U.S. The approval of Triferic AVNU increases the flexibility to deliver intravenously to a broader group of patients than before.

With each hemodialysis treatment, Tiferic is designed to deliver 5 mg to 7 mg of iron to bone marrow and to maintain hemoglobin without increasing iron stores or inflammation.

A week ago, the company entered a debt financing agreement with an affiliate of Innovatus Capital Partners LLC for up to $35 million in term loans, with $22.5 million funded at closing, and another $5 million drawn upon hitting milestones, such as the FDA approval for I.V. Triferic. A third tranche of $7.5 million is available to the company upon achieving milestones, including hitting certain Triferic sales thresholds.

Triferic Dialysate was launched in the U.S. in May 2019, according to Cortellis, the same month Rockwell submitted an NDA for the I.V. formulation. The FDA accepted the NDA filing in August 2019.

Rockwell said it plans to begin evaluation programs in the third quarter of 2020 and expects it to be commercially available once the programs are completed.

At midday, the Wixom, Mich.-based company’s stock (NASDAQ:RMTI) drooped about 6.5%, more than double that of the suffering Nasdaq index, which sagged 3%.

In January, Sun Pharmaceutical Industries Inc. agreed to develop and commercialize Triferic in India. The payment in the deal was unspecified. Rockwell's subsidiary, Rockwell Medical India, had marketing rights in India and Biorenal has commercialization rights in Chile, according to Cortellis. Aram Medical is investigating the drug in certain Middle Eastern countries, including Saudi Arabia.

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