Readying itself for what looks like a blockbuster victory lap in the cardiovascular field, Novartis ($NVS) has notched boasting rights for its heart drug LCZ696, gaining recognition in the U.K. as a "promising innovative medicine" that could be made available to patients ahead of formal marketing approval.
|Novartis Pharma Chief David Epstein|
The Medicines and Healthcare products Regulatory Agency, or MHRA, granted the designation earlier today as an opening move toward early access. And they were moved by the PARADIGM-HF Phase III study, which demonstrated some clear benefits in reducing cardio deaths.
The MHRA isn't going to get any kickback from Novartis. Novartis pharma chief David Epstein has already dubbed this drug a "megablockbuster" in the making. And Thomson Reuters just days ago estimated 2019 sales for this drug at $3.73 billion.
The stellar data and a breakthrough reputation on both sides of the Atlantic helped chill expectations for Amgen's ($AMGN) newly approved heart treatment Corlanor (ivabradine). Even some concerns about a potential link to Alzheimer's--recently outlined by French researchers--has barely shaken the faith for LCZ696.
Last month the MHRA selected Merck's Keytruda, the closely-watched PD-1 checkpoint inhibitor, as the pioneer therapy to win early market access in the U.K. Northwest Biotherapeutics ($NWBO), meanwhile, won the first PIM last fall for its cancer vaccine DCVax.
"Despite widespread use of available treatments and implementation of NICE heart failure guidelines, outcomes remain poor for those diagnosed, with around 60% dying from heart failure within five years," says Hugh O'Dowd, the general manager at Novartis UK & Ireland. "It is therefore very encouraging that LCZ696 has been recognised as a scientific innovation that can improve the lives of people living with this debilitating condition."
- here's the release