Merck's Lipfendra pill receives FDA approval as first oral PCSK9 cholesterol treatment

The U.S. Food and Drug Administration approved Lipfendra, an oral medication from Merck that lowers low density lipoprotein cholesterol.

The drug blocks the PCSK9 protein, making it the first pill of its kind; until now PCSK9 inhibitors have been injectable.

Approval covers use alongside diet and exercise for patients with high cholesterol, including those with heterozygous familial hypercholesterolemia, and follows a controversial FDA voucher program introduced by former commissioner Marty Makary.

Merck expects the oral format to improve adoption compared with injectable competitors such as Amgen's Repatha, which generated $3 billion in sales last year.