There will be an interruption in the supply of Keryx Biopharmaceuticals‘ Auryxia® (ferric citrate) tablets, the company’s kidney drug, on account of a production-related issue converting active pharmaceutical ingredient (API) to finished drug product at its contract manufacturer.
As a result of this interruption of supply, the company has exhausted its reserve of finished drug product and the current inventories of Auryxia aren’t enough “to ensure uninterrupted patient access to this medicine.”
According to a press release, “Keryx is working with its existing manufacturer to resolve the production-related issue and rebuild adequate supply. In addition, since approval of Auryxia in 2014, Keryx has been working to bring a secondary manufacturer online to supply finished drug product.”
The safety profile of the currently available Auryxia is not affected by the supply interruption, nor does the supply interruption affect the supply of ferric citrate (marketed as Riona®) manufactured and sold by Keryx’s Japanese partner.
Approved by the FDA on September 5, 2014, Auryxia is indicated for the control of serum phosphorus levels in patients with CKD on dialysis.
Once the supply of Auryxia is back to adequate levels, Keryx expects to make it available to patients—which the company currently anticipates being in the fourth quarter of 2016.
“We take our responsibility to patients and the treating community very seriously and recognize the impact this interruption of supply will cause for patients and their healthcare providers,” said Greg Madison, chief executive officer of Keryx Biopharmaceuticals. “Our field-based teams have been doing an outstanding job educating the community on the benefits of Auryxia and will be a critical resource during this supply interruption as we continue to support healthcare providers and their patients with hyperphosphatemia.”
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