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CAMBRIDGE, Mass., Might 18, 2020 /PRNewswire/ —Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical firm centered on the event and commercialization of therapeutics for individuals residing with kidney illness, introduced at present that its collaboration accomplice, Japan Tobacco, Inc. (JT), has filed a supplemental New Drug Utility (NDA) with the Prescription drugs and Medical Gadgets Company (PMDA) in search of a further indication for Riona® Tablets 250mg (generic identify in Japan: ferric citrate hydrate) to deal with grownup sufferers with iron deficiency anemia (IDA) in Japan. JT and its subsidiary, Torii Pharmaceutical Co., Ltd. (Torii), made a public announcement, which is out there right here: https://www.torii.co.jp/en/release/2020/20200515_E1.pdf.
The NDA relies on JT and Torii’s Section three medical research and different medical research in grownup sufferers with IDA in Japan. To entry the whole public announcement on the Section three research from JT and Torii, please go to: https://www.jt.com/media/news/2019/pdf/20190709_E01.pdf.
Riona was accepted in Japan in 2014 as an oral therapy for the advance of hyperphosphatemia in sufferers with continual kidney illness (CKD) each on dialysis and never on dialysis. Ferric citrate is accepted and marketed in the USA by Akebia beneath the commerce identify Auryxia® (ferric citrate) for the management of serum phosphorus ranges in grownup sufferers with CKD on dialysis and for the therapy of IDA in grownup sufferers with CKD not on dialysis.
“IDA can have a big affect on the well being and high quality of life of individuals residing with kidney illness. As an oral drug, Auryxia permits CKD sufferers not on dialysis, a high-risk inhabitants, to be handled for IDA whereas remaining safely at residence,” mentioned Michel Dahan, Senior Vice President and Chief Working Officer of Akebia. “We congratulate JT and Torii on their work and are excited by their progress towards increasing Riona’s label to deal with grownup sufferers with IDA in Japan.”
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About Akebia Therapeutics
Akebia Therapeutics, Inc. is a totally built-in biopharmaceutical firm centered on the event and commercialization of therapeutics for individuals residing with kidney illness. The Firm was based in 2007 and is headquartered in Cambridge, Massachusetts. For extra info, please go to our web site at www.akebia.com, which doesn’t kind part of this launch.
About Auryxia® (ferric citrate) Tablets
Auryxia (ferric citrate) was accepted by the FDA on September 5, 2014 for the management of serum phosphorus ranges in grownup sufferers with CKD on dialysis and accepted by the FDA on November 6, 2017 for the therapy of iron deficiency anemia in grownup sufferers with CKD not on dialysis. For extra details about Auryxia and the U.S. full prescribing info, please go to www.auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate) CONTRAINDICATION
AURYXIA® (ferric citrate) is contraindicated in sufferers with iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Will increase in serum ferritin and transferrin saturation (TSAT) have been noticed in medical trials with AURYXIA in sufferers with continual kidney illness (CKD) on dialysis handled for hyperphosphatemia, which can result in extreme elevations in iron shops. Assess iron parameters previous to initiating AURYXIA and monitor whereas on remedy. Sufferers receiving concomitant intravenous (IV) iron could require a discount in dose or discontinuation of IV iron remedy.
- Threat of Overdosage in Kids As a result of Unintentional Ingestion: Unintentional ingestion and ensuing overdose of iron-containing merchandise is a number one reason for deadly poisoning in kids beneath 6 years of age. Advise sufferers of the dangers to kids and to maintain AURYXIA out of the attain of kids.
Most typical adversarial reactions with AURYXIA have been:
- 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%), belly ache (5%) and hyperkalemia (5%).
- Being pregnant and Lactation: There are not any accessible information on AURYXIA use in pregnant girls to tell a drug-associated danger of main beginning defects and miscarriage. Nonetheless, an overdose of iron in pregnant girls could carry a danger for spontaneous abortion, gestational diabetes and fetal malformation. Knowledge from rat research have proven the switch of iron into milk, therefore, there’s a risk of toddler publicity when AURYXIA is run to a nursing girl.
To report suspected adversarial reactions, contact Akebia Therapeutics at 1-844-445-3799.
Please see full Prescribing Information
Kristen Ok. Sheppard, Esq.
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SOURCE Akebia Therapeutics
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