DOJ Subpoenas Documents from Alnylam Over Marketing of Onpattro

Rare Daily Staff

The U.S Department of Justice has delivered a subpoena to Alnylam Pharmaceuticals for documents relating to its marketing and promotion on Onpattro, the company treatment for hereditary ATTR amyloidosis.

In a terse filing with the U.S. Securities and Exchange Commission, Alnylam disclosed that the DOJ’s U.S. Attorney’s Office for the District of Massachusetts is requiring it to produce the documents relating to its marketing of the drug in the United States.

“The Company is preparing a response to the subpoena and cooperating with the government,” the company said. “Experienced outside legal counsel has been retained to assist with this matter.”

Alnylam in April 2018 won U.S. Food and Drug Administration approval for Onpattro, a first-of-its-kind RNA interference therapeutic, for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis, an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene. Mutations in the TTR gene cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy, as well as other disease manifestations.

The company reported $306 million in sales of Onpattro in 2020, an 80 percent increase from the previous year.