Novartis, after prior deal with NHS England, scraps large-scale Leqvio trial

After major fanfare in 2020 when Novartis and England’s National Health Service pledged to study the cholesterol-lowering drug Leqvio as a primary prevention med in patients with atherosclerotic cardiovascular disease, the company is changing course.

Under their prior partnership, Novartis and NHS England planned to study whether Leqvio could prevent the first occurrence of major cardiovascular events in U.K. patients with high cholesterol. Now, in part because of the pandemic, Novartis is changing the plan, Reuters reports.

“After careful evaluation, we have decided not to move forward with ORION-17, the UK-based primary prevention trial originally planned as part of the NHS England (NHSE) partnership,” a Novartis spokesperson told Fierce Pharma in an emailed statement.

The company will continue to study Leqvio in the high-risk primary prevention setting, the spokesperson said. A 14,000-patient trial in this indication kicked off in mid-March. That study is called the VictORION-1-PREVENT trial and it aims to enroll patients across 42 countries, including the U.S. and the U.K.

Under the Novartis and NHS England partnership, the pair also stipulated that they would provide the drug to high-risk patients at a discounted price in a world-first “population-level agreement.”

Novartis and England’s NHS remain “fully committed” to Leqvio and their partnership, the Novartis spokesperson said, noting that the drug “has already seen significantly faster patient uptake” in the U.K. compared with other similar drug launches.

“We continue to have very high ambitions for Leqvio and are encouraged by the foundation we have built and the traction we have seen so far, both in the UK and around the world,” the spokesperson added.

Novartis picked up Leqvio from its $9.7 billion acquisition of The Medicines Company in 2019. The drug nabbed approval in Europe in late 2020 to treat adult patients with hypercholesterolemia or mixed dyslipidemia in combination with a statin or with other lipid-lowering therapies.

The U.K.’s National Institute for Health and Care Excellence recommended the medicine in 2021.

In the U.S., the FDA approved Leqvio in late 2021 to lower and maintain cholesterol in adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who need additional cholesterol lowering.