First Medicine To Reduce Cardiovascular Risk Gets FDA’s Approval

It is the first U.S Food and Drug Administration approved the medicine for high-risk patients to reduce cardio risks like stroke and heart attacks. It is only FDA-approved medication for cardio risks, to date.

Cardiovascular risks affect millions of inhabitants in the United States and the estimated cost is 500 dollars, annually. All these high-risk patients can get benefit from this cost-effective therapy.

The cardio disease rate in the United States is so elevated that after every 14 seconds an event occurs and this costs so much economically as well as emotionally. It is the top one cause of deaths in the U.S. So there is an acute need for cost-effective and preventive-care treatment.

An independent drug pricing body evaluated that VASCEPA is cost-effective for risk reduction as demonstrated in REDUCE-IT cardiovascular study. In financial reporting, the total net earning guidance of VASCEPA has increased to a range of $410 to $425 million for 2019 and freshly guided to an estimated range of $650 to $700 million.

The president and chief executive of Amarin, John F. Thero showed gratitude and excitement for receiving FDA approval of VASCEPA for persistent risk reduction in patients who are facing problems even with the use of standard statin and other contemporary therapies. He addressed that his team is aimed to provide help to all those patients who are at high-risk, also statin-treated patients and statin-intolerant patients.

It is for the first time that there is an FDA- approved medication beyond lowering cholesterol levels which significantly turns down the major adverse events when used. He added that his team is working on spreading awareness about VASCEPA. They are educating the patients and physicians about its value and benefits.

The expanded indication and results of clinical trials are quite remarkable, helping physicians with important information and critical answers for addressing cardio diseases with their clinical judgment.

Amarin cleared and promote its intention to bang on the launch of VASCEPA as a new preventive care signifier in the United States. At the beginning of 2019, Amarin doubled its sales force as they disclosed it previously and now they are again destined to double the size to the 800 sales representatives near the start of 2020.

Interventional Cardiovascular Program’s executive director Deepal L. Bhatt, M.P.H considered VASCEPA’s approval by FDA as a major milestone in the prevention of cardiovascular diseases. VASCEPA (icosapaent ethyl) in addition to statin treatment for reducing the risk rate is a major achievement.

He is the professor at Harvard Medical School, and one of the investigators of the REDUCE-IT study. He claimed that it is the most significant event ever happened in the field of cardiovascular prevention after statin introduction which was almost done three decades ago. This is a historic achievement and millions of patients will get benefit from this.

Also read- NeuroTrauma Sciences and Emory University Sign Agreement for Stroke Research

REDUCE-IT trials have given confirmatory evidence that targeting the elevated triglycerides levels with isosapent ethyl reduces the risk of cardiovascular diseases with the guided baseline statin-therapy. These trials are the basis for the new drug application.

According to the study, almost 28% of patients undergoing treatment of standard statin and other contemporary therapies also experienced major adverse cardiovascular effects (MACE), heart attack, strokes, unstable angina or cardiovascular deaths.

A group of people who are already given statin therapy for lowering cholesterol levels still showed MACE occurrence, which demands alternative preventive care. In these trials, patients with pre-existing statin treatment, isosapent ethyl showed an absolute reduction of cardiovascular events by 4.8%.

Patients taking VASCEPA showed control and on average there is one rarely MACE occurrence per six patients as supported by a published analysis of the REDUCE-IT detailed study. There is almost a 30% risk reduction in MACE occurrence as compared to other therapies.




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