Trial failures of Novartis, Novo Nordisk heart drugs leave experts guessing

Resumen detallado

Novartis and co-developer Ionis Pharmaceuticals announced that their drug had failed to meet the trial’s main goal. Read more at straitstimes.com.

In September, Novartis and co-developer Ionis Pharmaceuticals announced that their drug had failed to meet the trial’s main goal.

CHICAGO – An experimental Novartis drug designed to treat a genetic cause of heart disease failed to reduce deaths and non-fatal heart attacks, dashing hopes for the first of several such drugs in clinical trials.

Despite a 78% reduction of the blood particle commonly known as Lp(a), a monthly dose of the Novartis drug, pelacarsen, over nearly five years had no effect in preventing a second heart attack or reducing the risk of stroke or need for emergency procedures to unblock clogged arteries in the trial of more than 8,300 patients, according to detailed results.

“Everybody in the world, me included, thought that this was going to work,” said Dr Steven Nissen of the Cleveland Clinic, who presented the results on Nov 7 at the American Heart Association (AHA) meeting in Chicago.

In September, Novartis and co-developer Ionis Pharmaceuticals announced that their drug had failed to meet the trial’s main goal, but experts and investors were eager for details to see if the treatment had some benefit.

“It didn’t do anything. It was completely neutral,” Nissen said in an interview.

A second failed study testing a Novo Nordisk drug aimed at reducing heart inflammation presented at the AHA meeting likewise hit the intended target of reducing inflammation, but failed to prevent major adverse cardiovascular events.

Taken together, the findings question some foundational theories about key factors underpinning heart disease.

Currently, there are no treatments for patients with high Lp(a), a genetic risk factor for heart disease estimated to affect roughly 20% of the global population, though few individuals know they have it.

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