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Novartis finalizes deal to make new heart drug widely available in England

Novartis has made a big bet on Leqvio and now the U.K. government has, too, motivated by the prevalence of heart disease and its strong links to high cholesterol. Leqvio came under the pharma’s control through a $10 billion acquisition of The Medicines Company in late 2019, after the smaller company had initiated and signed an agreement with the U.K. to run a prevention study.

Novartis expects billion-dollar sales for the drug, while the NHS hopes rolling the treatment out across the country will help prevent tens of thousands of heart attacks and strokes, as well as save thousands of lives over the next decade. According to the NHS, heart disease accounts for a quarter of annual deaths in England.

Persistently high cholesterol is a major risk factor, particularly in people who have already had a heart attack or stroke. Clinical testing showed Leqivo could dramatically lower cholesterol in people who are already taking statins or statins together with other lipid-lowering drugs.

Leqvio, also known as inclisiran, works by blocking production of PCSK9, a protein that increases LDL cholesterol levels. In that respect, the drug is similar to Amgen’s Repatha and Sanofi and Regeneron’s Praluent, both already approved in the U.S. and Europe. But Leqvio is taken once every six months, compared to Repatha’s and Praluent’s monthly or every-two-week dosing.

Under the partnership, nurses in England’s NHS can administer Leqvio in general practitioner’s offices, rather than in hospitals.

Leqvio costs nearly 2,000 pounds, or about $2,750, per 284-milligram pack, but NICE negotiated a deal for what NHS describes as an “affordable and cost-effective price.”

While Leqvio is approved in Europe, the same has yet to happen across the Atlantic. Last December, the Food and Drug Administration declined to approve the cholesterol therapy, citing in a letter “unresolved conditions” tied to an unscheduled inspection of a plant in Italy where Novartis makes the drug. Agency inspectors were unable to visit and inspect the site in person due to COVID-19 travel restrictions.

In a quarterly update, Novartis shared it had resubmitted its application to the FDA for Leqvio. An approval decision is expected by Jan. 1.

Novartis and the NHS did not specify exactly when patients will start receiving doses of Leqvio.