Statement from Akebia Therapeutics Regarding Litigation Against Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services
Akebia has one marketed product, Auryxia® (ferric citrate), which was approved by the FDA for the control of serum phosphorus levels in adult patients with CKD on dialysis, and for the treatment of iron deficiency anemia (IDA) in adult patients with CKD not on dialysis.
In 2018, the
Unfortunately, the federal district court denied our motion for a preliminary injunction and the
Given the importance of reestablishing CMS coverage for Auryxia for the treatment of IDA, many have stood alongside and supported Akebia in its efforts during the past two years. Several organizations filed amicus briefs with the district court expressing their support of our position, including the
We have spent considerable resources and time pursuing this lawsuit during the past two years. We are disappointed by the previous rulings denying our preliminary injunction and discouraged by CMS' continued unwillingness to extend Auryxia coverage for IDA to all kidney disease patients. After carefully considering next steps in this litigation, we have made the difficult decision to dismiss the case against CMS and HHS. Rather, we believe it to be in the best interest of our patients and Akebia to explore alternative approaches to secure coverage. We have had ongoing engagement with
All eligible patients deserve access to, and Medicare coverage for, critical, innovative therapies such as Auryxia for chronic kidney disease. We are proud of our efforts to work on behalf of patients toward these goals, which we believe are necessary to advance health equity. Our fight continues, and we remain committed to finding another path forward for those battling IDA and chronic kidney disease.
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
Akebia Therapeutics Contact
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