Akebia Therapeutics Announces Approval for Additional Indication of Riona® (ferric citrate hydrate) for the Treatment of Iron Deficiency Anemia in Adult Patients in Japan

Rhea-AI Summary

Akebia Therapeutics (Nasdaq: AKBA) announced that its partner, Japan Tobacco Inc. (JT), received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) for Riona^® Tablets (ferric citrate hydrate) to treat iron deficiency anemia (IDA) in adult patients in Japan. This approval follows the original marketing authorization obtained in 2014 for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients. Akebia's Auryxia^® has similar indications in the U.S.

Positive

• Approval of Riona for IDA treatment may expand the product's market potential in Japan.
• Strengthens collaboration between Akebia and Japan Tobacco, potentially enhancing sales.

Negative

• Expansion into Japan does not directly impact U.S. market performance or revenue.
• -

CAMBRIDGE, Mass., March 24, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA),  today announced that its collaboration partner, Japan Tobacco Inc. (JT), received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) for an additional indication for Riona^® Tablets 250mg (Riona) (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan.

JT and its subsidiary, Torii Pharmaceutical Co., Ltd. (Torii), made a public announcement, which is available here: https://www.jt.com/media/news/2021/pdf/20210323_E2.pdf.   

In 2014, JT obtained manufacturing and marketing approval for Riona, which is currently distributed by Torii as an oral treatment for improvement of hyperphosphatemia in adult patients with chronic kidney disease (CKD) both on dialysis and not on dialysis in Japan. Ferric citrate is also approved and marketed in the United States by Akebia as Auryxia^® (ferric citrate) for the control of serum phosphorus levels in adult patients with CKD on dialysis and for the treatment of IDA in adult patients with CKD not on dialysis.

"We congratulate JT and Torii on the expansion of Riona's label and thank them for the work they have done to bring a convenient oral medication to patients with IDA in Japan," said John P. Butler, Chief Executive Officer of Akebia.

The hyperlinks in this release do not form a part of this release.

About Auryxia® (ferric citrate) Tablets

Auryxia (ferric citrate) was approved by the FDA on September 5, 2014 for the control of serum phosphorus levels in adult patients with CKD on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. For more information about Auryxia and the U.S. full prescribing information, please visit www.auryxia.com.

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA^® (ferric citrate) CONTRAINDICATION
AURYXIA^® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.

WARNINGS AND PRECAUTIONS

• Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
• Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.

ADVERSE REACTIONS
 Most common adverse reactions with AURYXIA were:

• Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%).
• Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%).

SPECIFIC POPULATIONS

• Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.

To report suspected adverse reactions, contact Akebia Therapeutics at 1-844-445-3799.

Please see full Prescribing Information 

Contact
Kristen K. Sheppard, Esq.
ir@akebia.com

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SOURCE Akebia Therapeutics

FAQ

What recent approval did Akebia Therapeutics receive for Riona in Japan?

Akebia's partner, Japan Tobacco, received approval for Riona to treat iron deficiency anemia in adults.

When was Riona originally approved in Japan?

Riona was originally approved in Japan in 2014.

What is the significance of Riona's approval in Japan for Akebia stock (AKBA)?

The approval may enhance market potential for Akebia in Japan, but it does not immediately affect U.S. revenues.

What are Riona's current indications in Japan?

Riona is indicated for treating iron deficiency anemia and for hyperphosphatemia in chronic kidney disease.