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Pfizer "terminates" Lipitor OTC switch in US
Πέμπτη 30 Ιούλ 2015
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Pfizer has "terminated" its programme to switch the cholesterol-lowering drug Lipitor (atorvastatin) from prescription-to-OTC status in the US. Chief executive officer Ian Read said the company "continues to evaluate other products for potential prescription-to-OTC switches".
The company said its actual-use trial for Lipitor in a simulated OTC setting (click here to read the News story), which was completed in December 2014, had failed to meet the primary objective.

Pfizer explained that the study had not demonstrated "patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results".

"Based on the dialogue with the Food and Drug Administration (FDA) about the progamme and analysis of this data," said Pfizer, "the programme was terminated."

Despite the Lipitor setback, Read said Pfizer's Consumer Healthcare business was "tremendous". "At this moment, I think the Consumer business is a very valuable and growing asset for Pfizer," he added.

Switching the cholesterol-lowering drug to OTC status in the US was always going to be a challenge. Although another statin, simvastatin, was switched in the UK in 2004, previous applications to switch statins in the US had all been rejected by the FDA.

Cholesterol treatment gaps in the US

Discussing the potential Lipitor switch at a gathering of the European OTC industry in May 2015, Suneet Varma, Pfizer Consumer Healthcare's worldwide president, said "cholesterol treatment gaps" existed in the US despite the availability of prescription medicines (click here to read the News story).

Varma told delegates attending the 51st Annual Meeting of the Association of the European Self-Medication Industry (AESGP) in Barcelona, Spain, that around two-thirds of adults had been screened for cholesterol, but less than half of the 71 million adults with high levels of LDL-C were currently treated with a prescription medicine.

Noting that this left a large, untreated population, Varma said switching could provide an "incremental societal benefit".

Varma said a study carried out by the US National Consumers League had found that 82% of consumers said an OTC statin would be preferable to a prescription statin.

Furthermore, another study suggested that increased utilisation of statins following a switch in the US could prevent more than 250,000 coronary events and save more than US$8 billion over a 10-year period.

Πηγή:  OTC ToolBox

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