Akebia Therapeutics Announces Collaboration Partner’s Positive Top-line Results of Phase 3 Clinical Study of Riona® (ferric citrate hydrate) in Adult Patients with Iron Deficiency Anemia in Japan
Riona was approved in
“We congratulate JT and Torii on this important step toward expanding Riona’s indication and look forward to their progress to bring Riona to adult patients for the treatment of IDA in Japan,” stated
About JT and Torii’s Phase 3 Study in Iron Deficiency Anemia
JT and Torii’s public announcement highlighted that their study used a double blind, randomized and parallel-group design to evaluate the efficacy and safety of oral Riona in comparison to oral sodium ferrous citrate over seven weeks in adult patients with IDA. The companies have previously disclosed a target sample size of 480 patients. According to their announcement, “The top-line results show that the study met the primary endpoint by establishing non-inferiority of Riona compared with a control drug in the changes in hemoglobin level from baseline at week 7. Riona showed a favorable tolerability profile on safety within the treatment period. Regarding the safety endpoint, the incidence rates of nausea / vomiting (adverse events) were 13.0% / 3.2% (Riona) and 32.7% / 15.2% (control drug), respectively.”
Please visit https://www.jt.com/media/news/2019/pdf/20190709_E01.pdf to access the complete public announcement from JT and Torii, which does not form a part of this release.
About Auryxia® (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by the
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)
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.
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%).
- 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
Please see full Prescribing Information
Statements in this press release regarding Akebia’s strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to statements regarding the potential timing and basis of the application for approval of iron deficiency anemia as an additional indication for Riona in
Kristen K. Sheppard, Esq.