Abbott Laboratories is celebrating the news that US regulators have given the go-ahead to the firm’s cholesterol drug TriLipix.
The US Food and Drug Administration has approved TriLipix (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Approved as a monotherapy, Abbott noted that the drug is also “the first and only fibrate to be approved for use in combination with a statin”.
The approval was based on the results of three 12-week Phase III trials, which were designed to evaluate the treatment in combination with the three most commonly prescribed statins, and included a total of 2,698 patients with mixed dyslipidaemia. Abbott said that the data showed that all studies met their primary endpoints, with the combination treatments significantly improving HDL and triglyceride levels compared with statin therapy alone, as well as significantly improving LDL levels versus TriLipix alone.
The company cited Michael Davidson of the University of Chicago Pritzker School of Medicine as saying that “only 35% of patients with lipid problems are currently being treated with lipid therapies and many are not reaching treatment targets for all three key lipids”. Therefore the approval of TriLipix “is good news for patients because now there is a new treatment option that can be used alone or in combination”.
Abbott also noted that it is working with AstraZeneca to develop a drug that combines TriLipix and Crestor (rosuvastatin) and that the companies plan to file the drug with the FDA approval next year. The firms also recently announced an agreement under which Abbott’s sales force will co-promote Crestor in the USA.
Meantime the FDA has approved Genzyme Corp’s injectable Mozobil (plerixafor), intended for use in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin’s lymphoma and multiple myeloma undergoing stem cell transplantation.
Genzyme has filed the drug for marketing authorisation in the European Union and the company expects annual peak revenues for Mozobil in the transplant setting to be in the region of $400 million.
