Merck recalls Liptruzet on packaging defects
pharmafile | January 20, 2014 | News story | Manufacturing and Production | FDA, Merck, US, liptruzet, recall
Merck & Co has been forced to undertake a massive recall of its combination cholesterol-lowering drug Liptruzet in the US because its packaging may affect its effectiveness.
Liptruzet combines ezetimibe – the active ingredient in Merck’s Zetia – with widely-used generic cholesterol lowerer atorvastatin and was approved by the US Food and Drug Administration last year.
Merck said it is mounting a distributor-level recall of all lots of Liptruzet distributed since the product was launched in May 2013 – in all doses – because the foil pouches used to package the product may allow air and moisture to penetrate and affect the contents.
Merck – known as MSD outside North America – said the packaging of the product into the foil pouches is carried out by a contract manufacturing organisation (CMO), and a programme of corrective actions is now being implemented.
The company said the recall was a precaution and it had received no quality complaints or adverse event reports among people taking Liptruzet, noting that “the likelihood of the packaging defects decreasing the effectiveness of Liptruzet on a patient’s lipid profile or negatively impacting the safety of the product is remote.
“The recall will deplete all available supply in the US, and stock-outs are expected,” said the firm, which said patients on Liptruzet would be able to source Zetia and atorvastatin separately.
The financial impact of the recall on Merck is not expected to be that big, given that Liptruzet has not made significant headway into the marketplace in its first few months of sale.
As a monotherapy, Zetia made $1.9 billion in revenues in the first nine months of 2013, and Merck also sells a combination product with simvastatin – called Vytorin – that added another $1.2 billion to its top-line during the same period. So far, Merck has yet to reveal any sales figures for Liptruzet.
Meanwhile, Vytorin’s success arguably belies the data available on the product; it seems to be very effective at reducing LDL cholesterol but was unable to show a benefit over statins used alone on a key clinical measure, namely carotid intima media thickness (IMT) measured using ultrasound.
The puzzling data prompted suggestions that the priority for treatment should be optimising statin dosing – rather than adding ezetimibe – although an FDA review published in 2009 backed the use of Vytorin and effectively concluded that the lower a patient’s LDL cholesterol the better.
Merck is carrying out a large-scale cardiovascular outcomes trial called IMPROVE-IT to try to show ezetimibe provides a benefit above and beyond statin therapy, with results expected later this year.
When Liptruzet was approved Merck acknowledged that no incremental benefit of Liptruzet on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established.
Phil Taylor
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