Amgen and Ortho Biotech breathe collective sigh of relief after FDA panel vote

By Emilie Reymond

- Last updated on GMT

Related tags Erythropoietin Chronic kidney disease

Amgen and Ortho Biotech are breathing a sigh of relief after a
regulatory committee recommended not to change the label on their
blockbuster anaemia drugs when used in the kidney failure setting.

A panel of advisers to the US Food and Drug Administration (FDA) voted 14-to-5 on Tuesday not to recommend product label changes on Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), and Ortho Biotech's Procrit (epoetin alfa). The panel decided against lowering the recommended dose to 11 g/dL and said the drugs should continue to be given at target haemoglobin levels of 10 to 12 g/dL of blood for anaemic patients with kidney disease. The FDA announced in July it would ask two panels of experts to assess whether the drugs were safe in patients with anaemia caused by chronic kidney disease (CKD), after clinical data showed safety issues with the drugs when used at high doses. The decision is good news for both Amgen and J&J's subsidiary Ortho Biotech who over the past few months have both been bracing themselves for a potential erosion in sales of their drugs due to the intense scrutiny of erythropoiesis-stimulating agents (ESAs) - the class of drugs to which Amgen's and Ortho's top-selling drugs belong. Aranesp and Epogen sales alone reached almost $7bn (€5bn) last year - more than half of Amgen's total revenue. Most recently, the US Centers for Medicare and Medicaid Services (CMS) decided it would limit reimbursement of ESAs from next January. The new policy means that the CMS will no longer fully reimburse ESAs for patients with kidney disease whose haemoglobin levels are higher than 13 g/dL. The CMS decision came in response to safety concerns pinpointed by the FDA which recently warned that too high a dose of ESAs in patients receiving dialysis has dangerous side effects. ESAs are anti-anaemia biologics and manmade versions of erythropoietin, a hormone that is produced in the kidney, and stimulate the bone marrow to make more red blood cells. Ortho said it was "pleased with the recommendations of the FDA advisory committees". "Ortho Biotech supports the Committees' recommendation not to change the target hemoglobin, supporting the company's position that Procrit is a safe and effective therapeutic option in the management of anaemia in patients with chronic renal failure (CRF) when patients are treated according to the label,"​ said Marsha Wolfson, senior director of nephrology clinical affairs at Ortho Biotech. Commenting on the panel's vote, Amgen, the world's largest biotech company, said: "Amgen believes that ESAs play a critical role in managing the debilitating effects of anemia in patients with CRF. We look forward to continued discussions with FDA regarding the committees' recommendations and about the direction of future research exploring optimalanaemiamanagement for CRF patients." ​Amgen presented data to the committees in bid to demonstrate that ESAs are safe when used appropriately. The company's presentation recognised the potential risks observed in recent experimental trials targeting higher-than-recommended haemoglobin levels, laying out the need for an appropriate haemoglobin target of 10-12 g/dL to guide treatment and manage risk. A haemoglobin target range of 10-12 g/dL was included in the product labelling until March this year when the publication of clinical trial results highlighted safety concerns when ESAs are used to target hemoglobin levels of greater than 13 g/dL. The FDA then announced the addition of a black box safety warning to all ESA labels.

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