Amgen’s new drug Repatha does what is says but it is apparently not good enough. The drug trial results were highly anticipated and when Amgen disclosed the results, it proved to be a disappointment. The trial for Repatha was carried out on 27,000 subjects and the results showed that compared to placebo, the new treatment cuts the risk of heart attack, stroke and other cardiovascular problems by 15%. Unfortunately investors were expecting a reduction of 20-22%, so it is actually a disappointment from an investor’s viewpoint. Sean Harper, Amgen’s head of research and development disagree with this point of view, he pointed out that additional evidence from the study shows a risk reduction for heart attack and stroke by 33% when adjusted for “treatment lag”
Amgen’s shares took a nosedive and closed at $180.11 on Thursday. The FOURIER trial will also have far reaching consequences with regards to pricing. Repatha has a hefty price tag of $14,000 per year, and insurers are not very keen on paying for it. Since this drug came out in 2015, 75% of the prescriptions for this drug have been rejected.
The drug drops cholesterol level significantly, about 60 mg/dl, and it was presumed that the risk reduction would be at par as well. Additionally since it comes as an injection, it was considered as an added benefit as the chance of missing a dose would be less. Going by the drop in cholesterol, the drug was expected to cut cardiovascular disease risk by about 50%. The trial shows that for every 70 people on Repatha, one cardiovascular event was averted over a period of two years.
So far sales have only reached $141 million which is quite slow mostly because insurance companies aren’t keen to pay so much money without ironclad evidence of the drug’s benefits. The FOURIER trial was set up so that the clinical evidence for the drug’s effectiveness could be collected and the sales accelerated. But though Amgen is optimistic that the trial results meet those goals, experts are not so sure however.
“These Repatha results are disappointing,” said Dr. Ethan Weiss, a cardiologist and associate professor of medicine at the Cardiovascular Research Institute, University of California San Francisco.”A 15% relative reduction in risk for the primary endpoint is much lower than predicted based on prior trials. The top line here is that for this population, it is going to be hard to justify the cost of these [PCSK9] medicines for the magnitude of the risk reduction”.
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