A new class of drugs is poised to take on an insidious cause of heart attacks and strokes that has eluded treatment for decades.
Researchers could know as soon as this summer whether the most advanced experimental drug, from Novartis and its partner Ionis Pharmaceuticals, cut heart attacks, strokes and deaths in a study that could be used to get their drug approved by next year.
Amgen and Eli Lilly are also developing medicines that lower the level of lipoprotein(a), a fatty particle in the blood that is known as Lp(a). It can cause plaque to build up in blood vessels and is linked to heart disease.Tens of millions of people in the U.S. have elevated Lp(a), an inherited and largely hidden driver of heart disease. If Lp(a) drugs work, companies could be on the verge of the next big heart-drug market. Citi analysts estimate it could be valued at as much as $25 billion a year worldwide.
He went into cardiac arrest while at the hospital and required three rounds of cardiopulmonary resuscitation. He was airlifted to the Cleveland Clinic’s main hospital, where doctors performed an emergency procedure to remove blood clots from his arteries and heart.
When Heym woke up three days later, his doctor delivered the news: His Lp(a) level was more than triple the threshold at which the American Heart Association says it starts raising heart risk.Most people have never had their Lp(a) level tested, according to Nissen, the Cleveland Clinic cardiologist. Doctors have been hesitant to order the test for patients because there aren’t currently any approved drugs to directly lower the particle. Medical bodies updated guidelines earlier this year to recommend Lp(a) testing.
If the drugs work, the question will be who exactly should get them.
The drugs might prove clearly effective only for people with extremely high levels of Lp(a). If the benefit for patients with lower levels is murky, the drugs could end up being covered by insurers only for those at very high risk.
Then there is the question of cost: A decade ago, health plans balked at paying for powerful new cholesterol-lowering drugs called PCSK9 inhibitors because of pricing.
Drugmakers eventually slashed prices to about $200 a month from roughly $1,000 a month before insurers would cover them broadly. Analysts have estimated that the annual price for Lp(a) drugs could be similar to approved PCSK9 drugs—but a lot depends on the coming study results.
Amgen argues that near-total elimination of the particle is what will meaningfully reduce heart attacks and deaths.
“This could prove to be important, especially in patients who benefit from decades of improving other risk-factor management,” said Jay Bradner, Amgen’s executive vice president for research and development.