Amgen Korea released its cholesterol-lowering drug Repatha in the domestic market on Aug. 16, the company said at a Bio Talk session held at company headquarters Tuesday.
“The question is which patients are going to benefit the most from the drug,” said Dr. Han Ki-hoon from Asan Medical Center. “Amgen is at the early stages of expanding indications for Repatha, which will help it [gain market share].”
Repatha (ingredient: evolocumab) is a PCSK9 inhibitor that treats homozygous familial hypercholesterolemia (HoFH), a rare hereditary endocrine disease that leads to high levels of cholesterol in the blood. The Ministry of Food and Drug Safety approved the injectable medication in April, the company said.
Although accurate data on the number of Korean patients are unavailable, studies estimate around around one in one million patients have HoFH, according to Han.
Currently, there are two PCSK9 inhibitors in the global market – Amgen’s Repatha (ingredient: evolocumab) and Sanofi and Regeneron’s Praluent (ingredient: alirocumab).
The U.S. Food and Drug Administration approved both drugs in 2015, and the companies have since been locked in a battle to secure deals with health insurers in the United States and other countries for the pricey drugs.
Both drugs have a hefty price tag with Repatha amounting to $14,000 a year in the U.S.
The two companies have also engaged in the patent front with the court ruling in favor of Amgen in January, citing that Sanofi and Regeneron Pharmaceutical infringed upon the former’s patents.
Aside from the competition, both companies also face increasing pricing pressures that threaten the market.
Due to its cost, 75 percent of doctor prescriptions have been reportedly rejected by insurers in the U.S. This has led to dismal global sales of around $40 million in the third quarter of this year. Praluent fared no better, recording around $38 million in global third-quarter revenues.
Experts have also been dismayed by Amgen’s FOURIER clinical trial results, in which the drug met the primary endpoint by reducing cardiovascular risks such as heart attack and stroke by 15 percent, but failed to prevent deaths.
Experts are speculating how the drug will perform on the market as many have balked at the drug’s high price tag in the U.S.
The situation in Korea is little different, according to industry insiders. The drug will be sold similarly to the U.S., the company said.
The drug’s safety and efficacy were proved in TESLA-part B – a randomized, double-blind, placebo-controlled phase three trial conducted in ten countries in North America, Europe, the Middle East and South Africa, the company said.
The study included 49 patients above 12 years old with HoFH, randomly divided into two groups with one taking Repatha and the other a placebo. The study found Repatha significantly reduced ultracentrifugation LDL cholesterol at 12 weeks by 23.1 percent versus the placebo of 7.9 percent, indicating a 30.9 percent difference between the two groups.
The study also found no serious clinical or laboratory adverse events and no anti-evolocumab antibody development during the study, the company said.
Regarding domestic competition between Sanofi and Regeneron versus Amgen, Han noted that Sanofi’s drug does have more indications than Amgen’s. However, it is more important to monitor for adverse effects in the long-run.
Experts are now keeping tabs on how the drugs will fare in the domestic market amid rising pricing pressures and increasing competition.
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