Amgen, Inc. (NASDAQ:AMGN) is preparing to face the Federal Drug Agency with regards to the safety of its cholesterol drug.
The U.S. regulatory body will question the biotechnology firm on whether the drug’s cholesterol-lowering ability might be enough for it to be approved. Additionally the agency will want to know whether the drug will lead to some other complications such as heart conditions.
At the beginning of the week, the FDA sent a report to its advisors, requesting them to perform a close analysis of the issue when they meet to discuss the Rapatha drug. The meeting is set to take place later in the week.
Sanofi SA (ADR) (NYSE:SNY) and Regeneron Pharmaceuticals Inc (NASDAQ:REGN) are also facing a similar situation with their competing drug known as Praluent. The two cholesterol reducing drugs are set to receive a lot of attention. High cholesterol is one of the major catalysts for heart diseases. Therefore drugs that significantly reduce the level of cholesterol will be a significant addition to the pharmaceutical industry.
Of course the drug agency will not require a demonstration. However, they will require documented research that the drugs do not lead to unanticipated results before it can decide whether the drugs are safe.
The new drugs have been classified in a group of treatment known as PCSK9 inhibitors. They are the kind of drugs that are diagnosed for patients who are difficult to treat. Currently, most patients who are unable to regulate their weight to safe levels have been using Statins. One of the most popular statins is Lipitor from Pfizer Inc. (NYSE:PFE). The new drugs will particularly be a welcome addition for patients who are unable to use statins.
The FDA advisors will first meet to talk about Praluent before they move on to Repatha. Both drugs are being tested to identify what effects they have on the heart. The trials will be finalized by 2017. The drugs have the potential to bring in major changes and advances over many conditions if the FDA approves them.