The Medicines Co. (NSDQ:MDCO) and Alnylam Pharmaceuticals (NSDQ:ALNY) said today that they’ve reached a deal with the FDA over a Phase III trial for the companies’ RNA-based cholesterol-lowering drug, inclisiran. If approved, it would be the 1st RNA-interference therapy on the market.
The drug is a part of a new group of drugs called PCSK9 inhibitors. Anti-PCSK9 drugs from Amgen (NSDQ:AMGN) and Regeneron (NSDQ:REGN) have been on the market since 2015 and despite their ability to reduce low density lipoprotein cholesterol in clinical trials, the products have had trouble commercially.
Although the drugs provide an alternative to statins, which many patients can’t tolerate or don’t respond to, insurers and consumers are hesitant thanks to the $14,000 per patient annual price-tag. Combined, Amgen and Regeneron’s products made about $80 million globally in the last reported quarters.