The pandemic has dramatically slowed down clinical trials and potential approvals for a Novartis heart drug that’s expected to hit blockbuster status.
The first-in-class cholesterol-lowering siRNA treatment, Leqvio, was a centerpiece of Novartis’ $9.7 billion takeover of The Medicines Company in 2019. Although Novartis won approval for the drug in the EU in December, the company has been hit with an approval delay in the U.S.
Originally, the hope was that Leqvio would be one of the biggest approvals of 2020, but now the company is now grappling with the possibility that it may not receive an FDA nod until 2022. The delay was created after the company received a complete response letter (CRL) from the FDA because the agency was unable to inspect a facility due to travel restrictions.
On top of that, Novartis reported this week that a large study of the drug in the U.K. will likely be finished in 2026 — one year behind schedule — due to recruitment issues linked to the pandemic. Novartis is planning to use data form the study to help the National Health Service identify patients at a higher risk for heart disease who have not responded to standard treatments.
