WASHINGTON, June 8 (Reuters) – Amgen Inc’s experimental drug Repatha lowered cholesterol in clinical trials and did not cause a marked disparity in deaths or serious adverse events but showed potential safety issues that should be explored, according to a preliminary review by the U.S. Food and Drug Administration.
The review was published on Monday on the FDA’s website before a meeting on Wednesday of outside advisers to the agency who will discuss the drug and recommend whether it should be approved.
Repatha, also known as evolocumab, is designed to be given in biweekly doses of 140 mg or a monthly dose of 420 mg, along with statins, another type of cholesterol drug, or to patients unable to tolerate statin therapy.
The safety database submitted by Amgen was adequate but long-term data was limited, the FDA reviewer, Dr. Eileen Craig, found. A 52-week trial enrolled many patients who were not at high risk of cardiovascular disease and therefore were arguably not representative of the most appropriate patient population.
Potential safety issues, including an imbalance in the number of cases of pancreatitis and serious kidney disorders and a possible increased incidence of new onset diabetes in certain patients, could be adequately addressed in the drug’s labeling and by appropriate monitoring by healthcare providers, Craig said.
She added that if approved “these issues should be thoroughly explored in on-going studies.”
The agency asked the panel to consider whether dosing options for the drug allow sufficient flexibility to healthcare providers to titrate dosing downwards if needed.
The FDA is not obliged to follow the advice of its advisory panels but typically does so.
Repatha is one of a new class of cholesterol-lowering drugs known as PCSK9 inhibitors. Another drug in the class, Praluent, made by SAnofi SA and Regeneron Pharmaceuticals Inc will be considered by the panel on Tuesday.
(Reporting by Toni Clarke in Washington; editing by Andrew Hay)