Akebia Therapeutics Statement Regarding Litigation Against the Centers for Medicare & Medicaid Services and the US Department of Health and Human Services | Business

CAMBRIDGE, Mass., Oct. 25, 2021 / PRNewswire / – At Akebia Therapeutics, we are driven by a collective goal to improve the lives of those affected by kidney disease. As part of our mission to support patients with renal failure, we work on the development and commercialization of innovative therapies and we ensure that all patients, especially those disproportionately affected by renal failure chronic (CRI), have access to and be reimbursed for these essential therapies.

Akebia markets a product, Auryxia® (ferric citrate), which has been 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 CRF. not on dialysis.

In 2018, the Centers for Medicare & Medicaid Services (CMS) made the decision to deny coverage for Auryxia for one of these indications, the treatment of iron deficiency anemia (IDA), as part of the outpatient program of Medicare prescription drugs (Medicare Part D). We filed a complaint in October 2019 against CMS and the US Department of Health and Human Services (HHS) challenging their decision, hoping to restore coverage for these patients. We also asked the Federal District Court to issue an injunction to immediately restore coverage to Auryxia when used for IDA while the trial was ongoing. We filed the lawsuit and preliminary injunction because we believed people living with CRF were deprived of an FDA approved drug, in an approved indication, due to CMS removing full coverage from Medicare for the treatment of IDA with Auryxia.

Unfortunately, the Federal District Court denied our motion for a preliminary injunction, and the United States Court of Appeals for the First Circuit upheld the district court’s decision. However, the district court recently dismissed a CMS petition to dismiss our lawsuit, finding that a drug maker like Akebia had standing and met other jurisdictional requirements necessary to bring a lawsuit directly challenging a claim. CMS coverage decision. This is important because it opens the door for other biopharmaceutical companies to challenge illegal CMS coverage decisions in the future, rather than forcing patients to do so through a complicated and demanding appeal process. in resources.

Considering the importance of re-establishing CMS coverage for Auryxia for the treatment of IDA, many have supported and supported Akebia in its efforts over the past two years. Several organizations have filed amicus briefs with the district court expressing their support for our position, including the Medicare Advocacy Project of Greater Boston Legal Services, the Center for Medicare Advocacy, the Massachusetts Biotechnology Council, and the Biotechnology Innovation Organization (BIO). Other organizations have issued statements in favor of Akebia, including the American Kidney Fund, Dialysis Patient Citizens, and the National Kidney Foundation. In addition, members of Congress and several dozen nephrologists have submitted letters to CMS in support of covering Auryxia. We are grateful to have had such prestigious and committed individuals and organizations in our corner who advocate for patients with kidney disease.

We have devoted considerable time and resources to pursuing this legal action over the past two years. We are disappointed with previous decisions denying our preliminary injunction and discouraged by CMS’s continued reluctance to extend Auryxia coverage for IDA to all patients with renal failure. After carefully considering the next steps in this litigation, we have made the difficult decision to dismiss the case against CMS and HHS. Rather, we believe it is in the best interest of our patients and Akebia to explore alternative approaches to ensure coverage. We have had ongoing engagement with US lawmakers and are pursuing a legislative agenda that could secure Medicare coverage for Auryxia through a recently introduced bill.

All eligible patients deserve Medicare access and coverage for critical and innovative therapies such as Auryxia for chronic kidney disease. We are proud of our efforts to work on behalf of patients towards these goals, which we believe are necessary to advance health equity. Our fight continues and we remain committed to finding another way forward for those struggling with ADI and chronic kidney disease.

IMPORTANT SAFETY INFORMATION FOR AURYXIA® (ferric citrate) CONTRAINDICATION AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, eg hemochromatosis.

Iron overload: Increases in serum ferritin and transferrin saturation (TSAT) have been observed in clinical trials with AURYXIA in patients with chronic kidney disease (CRF) on dialysis and being treated for hyperphosphatemia, which may cause excessive increases in iron stores. Evaluate iron parameters before initiating AURYXIA and monitor during treatment. Patients receiving concomitant intravenous (IV) iron may require dose reduction or discontinuation of IV iron therapy. less than 6 years old. Advise patients of the risks to children and keep AURYXIA out of the reach of children.

ADVERSE REACTIONS The most common side effects with AURYXIA were:

Hyperphosphatemia in CRF on dialysis: diarrhea (21%), discolored stools (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Iron deficiency anemia in CRF Not on Dialysis: discolored stool (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%).

Pregnancy and breast-feeding: There are no data available from the use of AURYXIA in pregnant women to inform of a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women can lead to a risk of spontaneous abortion, gestational diabetes and fetal malformation. Data from studies in rats have shown transfer of iron to milk, therefore, there is a possibility of infant exposure when AURYXIA is given to a nursing woman.

To report suspected side effects, contact Akebia Therapeutics at 1-844-445-3799.

SOURCE Akebia Therapeutics

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