Pfizer says that its blockbuster cholesterol-lowerer Lipitor, which has been the subject of numerous patent challenges of late, has been given the green light by US regulators in five new indications.
The company noted that the US Food and Drug Administration has approved Lipitor (atorvastatin) to reduce the risk of non-fatal heart attacks, fatal and non-fatal strokes, certain types of heart surgery, hospitalisation for heart failure, and chest pain in patients with heart disease. This makes the drug the first cholesterol-lowering medication to receive FDA approval for the reduction of the risk of hospitalisation for heart failure, the New York drugs giant noted, as previously Lipitor was approved to reduce cardiovascular events in patients without heart disease.
The new approvals are based on the five-year ‘Treating to New Targets’ (TNT) study which involved 10,000 patients with both heart disease and elevated LDL or 'bad' cholesterol levels. It showed that patients taking Lipitor 80mg had a significant (22%) reduction in the risk of major cardiovascular events over and above patients taking Lipitor 10mg. In addition, patients treated with the higher dose had a significant 26% reduction in the risk of hospitalisation for heart failure.
John LaRosa, professor of medicine at the State University of New York Downstate Medical Center and lead investigator on the TNT trial said that many patients who have heart disease remain at risk for another cardiovascular event “and now these indications broaden the means to reduce their risk." The approvals should also benefit the company’s efforts to defend Lipitor against generic competition as Pfizer has been battling hard in the courts to protect the world’s biggest-selling drug from copycat manufacturers. Last year’s sales reached $12.8 billion.
Pfizer ordered to withdraw Zyvox ads
There was less good news for the Pfizer in the UK as the Medicines and Healthcare products Regulatory Agency (MHRA) asked the firm to withdraw an advertisement making “potentially misleading claims” about the antibiotic Zyvox (linezolid).
The MHRA said it became aware of the advertisement in the British Medical Journal which claimed that Zyvox has superior cure rates compared to products containing vancomycin. At the time, Pfizer was in discussion with the agency about “emerging concerns relating to the efficacy and safety of Zyvox compared to vancomycin in a clinical trial in patients with catheter-related infections.”
Pfizer promptly suspended all advertising that includes this claim, the MHRA noted, adding that the company has also informed healthcare providers about new safety restrictions related to the antibiotic.