FDA Approves Boehringer Ingelheim’s Heart Failure Treatment

March 15, 2022 - FDA recently approved Boehringer Ingelheim's Jardiance to reduce the risk of cardiovascular death and hospitalization in heart failure in adults.

The agency based its approval on the safety and effectiveness of Jardiance, which were evaluated as an adjunct to standard of care therapy in a randomized, double-blind clinical trial. In the trial, 2,997 participants received 10 milligrams of Jardiance once daily, and 2,991 participants received the placebo.

Of the individuals who received Jardiance for an average of two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of patients who received placebo.

The side effects in clinical studies for patients with heart failure were generally consistent with side effects for patients with diabetes, FDA highlighted.

"Today's approval will provide a treatment option for a wider range of patients with heart failure," said Norman Stockbridge, MD, PhD, director of the division of cardiology and nephrology in the FDA's Center for Drug Evaluation and Research, said in the announcement.

"While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure. Coinciding with February's annual observance of American Heart Month—a reminder for individuals to focus on cardiovascular health—this action will provide physicians another tool to address heart disease," Stockbridge continued.

In March 2020, FDA granted fast track designation to Jardiance to treat chronic kidney disease. Then in September 2021, FDA granted breakthrough designation to Jardiance to treat adults with heart failure with preserved ejection fraction.

And in November 2021, Jardiance slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40% regardless of chronic kidney disease status at baseline in a Phase 3 trial.

FDA Approves J&J's Cell Therapy For Multiple Myeloma

FDA recently approved Johnson & Johnson's T-cell (CAR-T) therapy, Carvykti, to treat adult patients with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy.

The agency based its decision on results from the CARTITUDE-1 study, which enrolled patients who received a median of six prior treatment regimens and previously received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

In the study, patients who received Carvykti experienced an overall response rate of 98%. Notably, 78% of patients achieving this level of response experienced a stringent complete response. And at an 18-month follow-up, the median duration of response was 21.8 months.

"We are committed to harnessing our science, deep disease understanding and capabilities to bring forward cell therapies like CARVYKTI as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma," Peter Lebowitz, MD, PhD, global therapeutic area head, oncology at Janssen Research & Development, said in the announcement.

"We extend our sincere gratitude to the patients, their families and the teams of researchers and study centers who have participated in the clinical study of CARVYKTI and enabled today's approval," Lebowitz continued.

Johnson & Johnson and clinical-stage biotechnology company, Legend Biotech, will scale production capacity and increase the availability of Carvykti throughout the US in 2022 and beyond through a phased approach.

FDA Approves Expanded Indication for Abbott's Heart Failure Device

FDA recently approved Abbott's expanded indication for its CardioMEMS HF System to support individuals living with heart failure.

The expanded indication includes an additional 1.2 million US patients eligible to benefit from advanced monitoring with the CardioMEMS sensor. The approval marks a significant increase over the current target population.

FDA initially approved the CardioMEMS HF System in 2014 for use in New York Heart Association (NYHA) Class III heart failure patients with a prior heart failure hospitalization within the last year.

Now, providers can use the system in Class II heart failure patients and patients who undergo a blood test showing elevated biomarkers known as natriuretic peptides. Overall, the system provides an early warning system allowing doctors to protect against worsening heart failure. 

"Heart failure is a race against time where too often we're behind because patients are not getting care early enough," Philip B. Adamson, MD, chief medical officer of Abbott's heart failure business, said in the announcement.

"This expanded indication means physicians can treat more people with earlier-stage heart failure, providing the opportunity to prevent further suffering and possibly avoid later-stage progression that can have a profound impact on a person's quality of life," Adamson continued.