Alnylam Pharmaceuticals' RNA interference treatment, zilebesiran, demonstrated the ability to reduce blood pressure for six months in a mid-stage clinical trial. The company aims to develop zilebesiran as an add-on or alternative to daily blood pressure medications.
The FDA has rejected Alnylam Pharmaceuticals' plans to expand the label of its siRNA injection Onpattro for the treatment of ATTR cardiomyopathy, issuing a complete response letter. This decision comes after an advisory committee voted 9 to 3 in favor of the drug's benefits outweighing its risks. The FDA raised concerns about the effect size in this indication, with independent experts agreeing that while Onpattro's benefit was small, the risks were smaller for patients experiencing malformed protein buildup in the heart.
The FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in favor of Alnylam Pharmaceuticals' Onpattro for the treatment of ATTR cardiomyopathy, with panelists agreeing that the benefits outweigh the risks. While acknowledging the limited benefits, committee members expressed hope that clinicians would counsel patients on this treatment option.