Amgen recalls almost 1 million bottles of heart failure drug over quality issue

 

The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy.

Amgen has recalled almost 1 million bottles of its chronic heart failure drug Corlanor in response to a contamination concern.

The FDA attributed Amgen’s action to the presence of a foreign substance. Amgen began the voluntary recall of 934,577 bottles of the 5-mg Corlanor tablets last month. The recalled products are a mix of 14- and 60-tablet bottles of Corlanor. Amgen also recalled an undisclosed number of bottles of 7.5-mg tablets. Expiry dates for the recalled 5- and 7.5-mg tablets range from July 2026 to December 2028.

California-based Amgen listed Italy as the country where the medicines were made. The company has international manufacturing facilities in Ireland, the Netherlands and Singapore, but it also works with third-party contract manufacturers.

The FDA categorized the action as a Class II recall, indicating that the drug may cause temporary health consequences but the probability of a serious health issue is small. The recall notice lacks information about whether adverse events are linked to the recalled products.

Amgen won FDA approval for Corlanor in 2015. The drug, which Amgen licensed from Servier, reduces the spontaneous pacemaker activity of the cardiac sinus node to slow the patient’s heart rate. In doing so, Corlanor cuts the risk of hospitalization for worsening heart failure.

Corlanor represents a minor revenue stream for Amgen. In its first-quarter results, Amgen grouped the medicine with 12 other drugs that generated sales of $315 million collectively. Corlanor was too small a product even early in its lifecycle to have its own line on Amgen’s financial results.

The FDA shared details of the Corlanor recall alongside information about issues with another Amgen drug, Sensipar. Amgen has recalled 9,565 bottles of the chronic kidney disease (CKD) drug made in Japan over deviations from current good manufacturing practices. The FDA approved Sensipar in 2004, clearing the drug for use in treating secondary hyperparathyroidism in CKD patients on dialysis.

Sensipar is among the products that Amgen grouped with Corlanor in its first-quarter results. The drug, which Amgen sells as Mimpara in Europe, was once among the company’s best-selling products. Sensipar sales exceeded $1 billion in 2013 and peaked close to $1.8 billion in 2018, only to decline significantly after generic copies came to market.

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