13 Jul InvivoSciences gearing up for FDA application on heart failure drug
InvivoSciences, a pre-clinical stage biotech firm based in Madison, is gearing up for a potential FDA application for a heart failure drug and companion diagnostic tool.
But first, company leaders plan to meet with officials at the federal agency to get feedback ahead of making any submission. That’s according to Ayla Annac, president and CEO of the startup company.
In an interview yesterday, she highlighted a “severe unmet need” for drugs to effectively treat patients for a specific form of heart failure using precision medicine. She noted this approach, which involves matching disease prevention and treatment to specific patients and populations, is already being successfully applied to cancer treatment.
“Similar things need to happen in the heart failure area,” she told WisBusiness.com.
InvivoSciences has developed a drug candidate for this purpose, which was identified using the company’s existing drug development platform.
“The FDA meeting will not only go for the drug approval, but also for the companion diagnostic that we are developing for the stratified patient population that matches this drug,” she said, adding a meeting is expected to occur later this year.