Novartis sues FDA over ‘unlawful’ approval of generic heart failure drug
Novartis has filed a new lawsuit against the U.S. Food and Drug Administration (FDA) after the agency approved a generic version of Entresto, the company’s popular heart failure drug. In its complaint, which calls out U.S. Department of Health and Human Services Xavier Becerra and FDA Commissioner Robert Califf, MD, by name, Novartis claims this approval of a generic version of Entresto was “unlawful” and that the company will suffer significant harm.
Entresto is the brand name Novartis gave to its sacubitril and valsartan tablets sold in multiple doses to treat congestive heart failure in both adult and pediatric patients. It is the company’s top-selling medication and has been available in the U.S. market in some capacity for nearly a decade.
On July 25, the FDA approved a generic version of the sacubitril and valsartan tablets being sold by India-based MSN Laboratories. According to Novartis, MSN Laboratories rewrote certain indications for the drug to avoid violating the company’s patents. Novartis also claims that the labeling of the generic drug “unlawfully deletes critical safety information” and the actual drug has a different chemical structure than Entresto.
The Novartis complaint also emphasizes that this approval could do the company significant economic harm.
“Because revenues from Entresto form a critical part of Novartis’s ability to fund research and development, unlawful entry of purported generic products would undermine Novartis’s ability to invest generously in research and development,” according to the lawsuit. “The harms resulting from the lost investment could not be remedied after the fact. Progress toward developing critical new therapies will have stalled, and Novartis will have been subjected to significant risk of falling behind its competitors.”
For these reasons, and others, Novartis has been working to stop this approval for quite some time, sending multiple requests to the FDA. The FDA has rejected all of those requests, however. The agency’s most recent response—a 45-page denial—can be read here.
The Novartis lawsuit, dated July 30, was filed in the U.S. District Court for the District of Columbia. LAW360 first identified the complaint.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.