Pfizer cholesterol drug succeeds in two late stage trials

Pfizer's bococizumab cholesterol drug has met primary endpoint in two phase 3 trials, part of a series of six late-stage studies.

The company said the drug met endpoint in the SPIRE-HR and SPIRE-FH trials, assessing its safety and effectiveness in patients at high risk of cardiovascular events, and familial hypercholesterol, respectively.

These are the third and fourth in the series of six trials assessing safety and efficacy of the drug, a PCSK9 inhibitor.

Aside from the six phase 3 trials assessing the drug's lipid-lowering efficacy, there are two cardiovascular studies.

Pfizer's drug, thought by some to have blockbuster potential, will not be first to market as Amgen and Sanofi have already launched rivals, Repatha (evolocumab) and Praluent (alirocumab).

However Repatha and Praluent have got off to a slower start than expected, partly thanks to restrictions on use and a push back on prices in the all-important US market.

But Pfizer says the phase 3 programme for bococizumab is the only PCSK9 inhibitor programme with a dedicated cardiovascular outcomes study explicity assessing cardiovascular outcomes in high-risk primary and secondary prevention patients with high cholesterol, despite statin treatment or intolerance.

James Rusnak, chief development officer, cardiovascular and metabolic disease at Pfizer, said: “Our goal with the extensive SPIRE clinical programme is to evaluate whether bococizumab not only reduces cholesterol, but also reduces the risk of cardiovascular events in a broad range of high-risk patients, including those without a history of heart disease.”

Success with the new drug would provide Pfizer with a belated follow-up to Lipitor (atorvastatin), the world's biggest selling drug until it went off-patent five years ago. At its peak, Lipitor had brought in annual sales of around $14 billion.

AstraZeneca faces a statin patent cliff this year, with the expiry of the US patent on its Crestor (rosuvastatin), which pulled in sales of $5 billion in 2015.