CDSCO Denies Amgen, Inc. (NASDAQ:AMGN) Clinical Trial Waiver For Repatha

The Central Drugs Standard Control Organization (CDSCO) has hampered the plans of Amgen, Inc. (NASDAQ:AMGN) to quickly commercialize Repatha (evolocumab), a proprotein convertase subtilisin/kexin type 9 (PCSK9) drug, in India.

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Clinical Trial Waiver Scheme

Amgen filed a clinical trial waiver requesting the exemption of Repatha from preliminary testing among Indians to quickly bring the drug in the nation.

CDSCO had developed the clinical trial waiver scheme in India to support the quick launch of qualified drugs that are already commercialized in notable markets such as the US and Europe. With an approved clinical trial waiver, pharmaceutical companies can skip Phase II clinical trials in India. However, they are mandated to monitor—until fully established—the safety and efficacy of the drugs among Indian patients once they have been marketed. Qualified drugs include those that are intended to treat rare conditions and illnesses that come with few treatment alternatives.

Repatha’s Denied Clinical Trial Waiver

In the US and Europe, Repatha is well-regulated for the treatment of numerous conditions. It is commonly prescribed to patients with high cholesterol levels that cannot take statins.

The CDSCO Subject Expert Committee that had assessed whether or not Amgen should be granted a clinical trial waiver for Repatha deemed that the safety of the drug is established. Moreover, it has passed as an orphan drug for the treatment of homozygous familial hypercholesterolemia (HoFH). However, the CDSCO SEC noted that Repatha can potentially be misused to treat other conditions, and on the reasoning that people with other conditions may be able to make use of it on their doctors’ advice, it was denied to people who can actually benefit from it legally.

The company has been vague as to how it seeks to proceed with its plans now that the timetable for the Indian launch of Repatha is affected. Amgen, however, ensured that it will continue to closely work and cooperate with Indian regulators to market Repatha in India as soon as possible.

New Repatha Abstracts

On Monday, the company has revealed that a total of 11 abstracts will be presented at the five-day European Society of Cardiology (ESC) Congress, which will begin on Sunday.

The Repatha abstracts include clinical data evaluating the drug across ESC or European Atherosclerosis Society (EAS) cardiovascular (CV) risk subgroups and its safety and efficacy for the treatment of heterozygous familial hypercholesterolemia (HeFH).

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