Esperion Therapeutics Inc (NASDAQ:ESPR) has officially made it public that the Food and Drug Administration has confirmed that its low-density lipoprotein cholesterol (LDL-C) lowering program is lacking in terms of the guidelines it operates with in making the various approvals.
By first quarter of 2019, Ann Arbor, which happens to be a company based in Michigan dealing with development and well as commercialization of treatments for LDL-C patients intends to file a New Drug Application with FDA, which will be subject to some successful completion of Phase 3 ongoing trial.
Esperion also has put plans in place to file for a Marketing Authorization Application which will as a matter of fact be carried out with the European Medicines Agency. It will be taking place around the same time.
The Phase 3 program is made up of some four different studies and each of the studies is characterized by varying symptoms in the expansive patient population. Variations in the above mentioned studies comprise of patients with hypercholesterolemia, which is an indication of very high levels of cholesterol in the human blood.
Others are those considered “statin-intolerant,” ones capable of tolerating les than the lowest approved daily dose of stain and above all those ones consuming low does of statin with ezetimibe. Statins are known for their great effectiveness towards lowering the cholesterol levels.
Bempedoic acid, which happens to be Esperion’s drug, will most probably be used as an adjunct to statin therapy for the different patients suffering from hypercholesterolemia, which is a state associated with very high cholesterol levels in the human blood stream. Whenever a patient gets subjected to the primary or initial therapy, he or she is also given Adjunct therapy which goes along way to maximize effectiveness.
by mid-2018, conce4ned parties may receive the results about drug’s ability to lower LDL-C .At this particular moment, the company is full of expectations that indeed bempedoic acid will go along in serving the different physicians with a complementary as well as a convenient oral treatment option that will be cost-effective for its large number of patients struggling with hypercholesterolemia.
