US FDA Approves Vascepa, A Highly Purified Omega-3 Fatty Acid Heart Drug To Expand Label
A panel of specialists from the US Food and Drug Administration has approved allowing Amarin Corp Plc's fish-oil derived drug, Vascepa
to be used as an add-on therapy for reducing the chance of heart attack and stroke in high-risk patients with cardiovascular disease.
Everyone of the 16 panelists voted that the drug
should be sold as a medicine to reduce the risk of cardiovascular events like stroke and heart attack, agreeing that the drug was both safe and effective. The approval could open up the potential patient population to 10 million from 600,000 currently.
A key debate for panelists was to what extent the label should broadened, and whether patients who have not had a stroke, or have cardiovascular disease, benefit. The conversation also centered on how high patients’ triglycerides, a type of fat in the blood, must be to benefit.
Dr Susan Ellenberg, a panelists told Thailand Medical
News via a phone interview in reference to patients who had not had something like a heart attack or stroke and are at a lower risk, “There are some uncertainties here and there with these data but most of them relate to their primary prevention cohort. My feeling is that I may tend to leave it to clinical judgment about who should get” the drug.”
Another panelist Dr James de Lemos was more skeptical, saying Vascepa
“should be approved for secondary prevention only,” with the company needing to study Vascepa against a placebo in those lower risk patients.
The potential patient population could reach five to 15 million in the U.S., though only having one million patients on the drug would still make it a $2.5 billion medicine.
The FDA recommendation clears a big hurdle for what could result in more than $1.5 billion in annual sales, according to Wall Street analysts, and may set up Amarin for an outright sale to a larger drugmaker looking to bolster its portfolio of heart drugs. Vascepa
, which is currently sold in a more niche population of adults with severely high levels of triglycerides, could bring in more than $4 billion a year in peak sales, depending on the drug’s label.
Panelist Dr Anna McCollister-Slipp said in the group’s discussion period, “My inclination is to let something go onto the market that does have demonstrated benefit.”
Although the FDA panel agreed that Vascepa
’s label should be expanded, the ultimate decision of how large the potential patient population will be lies in the FDA’s hands. The wording of the panel voting question leaves the potential population to the agency’s discretion. U.S. regulators are expected to make a final decision by Dec. 28, and while the agency typically heeds the advice of its panels of experts, it isn’t obligated to.
In the United States, cardiovascular disease leads to one in every three deaths, with annual treatment costs in excess of $500 billion, according to Amarin.
Patients with high triglycerides, who also have complications like diabetes, are especially vulnerable to recurring cardiovascular complications.
The drug Vascepa
has earlier won the vote of confidence from major medical communities including the American Heart Association, American Diabetes Association as a treatment to help lower the chance of heart attacks and strokes.
Read Previous Article About Vascepa: https://www.thailandmedical.news/news/vascepa-set-to-steal-market-share-from-statins-