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LONDON (Reuters) - A new type of cholesterol drug from Sanofi and Regeneron Pharmaceuticals won a green light from European regulators on Friday, two months behind a rival product from Amgen.
The European Medicines Agency (EMA) said its experts had recommended Praluent for patients unable to control their cholesterol despite taking optimal doses of conventional statin pills or those who cannot take statins.
Praluent and Amgen's Repatha, which are both given as injections, will cost much more than statins but they offer a way to reduce cholesterol levels significantly for patients at high risk of heart problems.
They belong to a drug class known as PCSK9 inhibitors and are expected to generate global annual sales of more than $2 billion each by 2020, according to consensus forecasts compiled by Thomson Reuters Cortellis.
Amgen's Repatha was formally approved by the European Commission on Tuesday after a positive EMA opinion in May and Praluent is likely to be cleared by the Commission after a similar period.
Sanofi and Regeneron said they expected the Commission to make a final decision on the marketing application for Praluent in late September.
In the United States, the tables may be turned, since the Food and Drug Administration is due to give its verdict on Praluent by July 24, potentially putting Sanofi and Regeneron's product ahead of Amgen's.
The companies are heading for a major marketing fight, given the two drugs' similar mode of action, although there are significant differences in dosing that will play an important role in determining how they are used.
The EMA recommendation covers both a 75 mg and 150 mg dose of Praluent for treating adults with a genetic predisposition to high cholesterol and those whose cholesterol cannot be adequately controlled with existing medicines.
"Despite statins and other lipid-lowering therapies, many patients are unable to reach their LDL cholesterol goals and may benefit from new therapeutic options such as Praluent," said Sanofi research head Elias Zerhouni.
Both Praluent and Repatha have been shown to cut LDL cholesterol levels dramatically in clinically trials, although their ability to reduce the risk of cardiovascular deaths has not yet been determined. Further studies are now underway to establish this.
The competing products target the PCSK9 protein that maintains "bad" LDL cholesterol in the blood. Statins, like Pfizer's Lipitor, work very differently, blocking the liver's production of LDL cholesterol, which is linked with heart attacks and strokes.
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Overall, patients treated with PCSK9 inhibitors had higher rates of nonspecific side effects, such as arthralgia, headache, limb pain and fatigue, compared with placebo-treated patients. There were also more injection-site reactions in subjects treated with PCS9 inhibitors.
However, clinicians were most concerned about neurocognitive events. According to Mennen, "Overall, 1% to 1 ½ % of patients experienced treatment-related neurocognitive effects, mainly confusion and some memory loss. However, it’s important to note that the neurocognitive issues were not related to the amount of LDL-C decrease."
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