Bumper day for Novartis FDA approvals

Wednesday saw Swiss pharma giant Novartis (NOVN: VX) gain approval from the US Food and Drug Administration for Leqvio (inclisiran) and an added indication for Cosentyx (secukinumab).

The FDA approved Leqvio, the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one at three months. A year ago, the FDA issued a complete response letter on the new drug application (NDA) for inclisiran, due to unresolved facility inspection-related conditions.

“Leqvio is a revolutionary approach to lower LDL-C, and creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time,” said Vas Narasimhan, Novartis’ chief executive, adding: “We now have the opportunity, working together with partners, to provide this first-ever approved LDL-C–lowering siRNA-based therapy to tackle ASCVD at scale across the United States.”