Amgen has racked up another positive phase III trial for its cholesterol-lowering antibody evolocumab, cementing the drug’s blockbuster-in-waiting status.
The antibody – a member of the much anticipated PCSK9 inhibitor class that also includes Regeneron/Sanofi’s alirocumab (REGN727) candidate and Pfizer’s bococizumab – was effective in reducing cholesterol in patients who cannot tolerate statin drugs.
While statins are generally very effective in managing blood cholesterol levels, somewhere between 5 and 15 per cent of patients with elevated cholesterol are unable to take them because of side effects.
In these people alternative therapies, such as Merck’s Zetia (ezetimibe), are used to try to meet treatment goals, and Amgen is banking on evolocumab taking a leadership position among this group of patients.
The latest phase III trial of evolocumab – called GAUSS-2 – showed that evolocumab achieved its primary objectives of reducing LDL cholesterol compared to Zetia therapy at weeks 10 and 12 of therapy.
Earlier trials of Amgen’s drug showed that it was able to reduce LDL cholesterol levels by around 50 per cent, with Zetia only managing a 15 per cent reduction. And last month the company reported that the antibody was more effective than Zetia or the statin atorvastatin in reducing LDL cholesterol after 52 weeks’ therapy.
The data from the GAUSS-2 study is being prepared for presentation at a medical conference later this year. All told, Amgen is carrying out 13 phase III trials of evolocumab – which will collectively enrol around 28,000 patients – and it hopes to file its first marketing applications for the drug later this year.
“The positive GAUSS-2 results suggest that evolocumab may offer a new lipid-lowering treatment to meet an important medical need for high-risk patients who cannot tolerate effective doses of statins,” commented Amgen’s head of R&D Sean Harper.
If approved for marketing and assuming a launch in 2016, analysts at Deutsche Bank have suggested evolocumab could achieve peak sales of $2.5bn in 2020.