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