Entresto Sales See Slow and Steady Upturn

Patrice Wendling

October 25, 2019

After an initial lukewarm reception, US sales of the heart failure drug sacubitril/valsartan (Entresto) grew to more than $1.2 billion this year, Novartis executives told investors this week.

US sales of sacubitril/valsartan were up 61% from $271 million in the third quarter of 2018 to $430 million for the same quarter this year.

"We just have this continued solid, steady uptake in TRx [total prescriptions] in the US and we see a similar trend in other key markets around the world," Novartis chief executive officer Vas Narasimhan, MD, told reporters during the call Tuesday.

Despite narrowly missing its primary end point of heart failure (HF) hospitalization or cardiac deaths among patients with HF and preserved ejection fraction in PARAGON-HF, subgroup analyses in patients with an ejection fraction up to 57% and women showed significant benefits, he said.

After discussions with the US Food and Drug Administration (FDA), the company plans to move forward with a regulatory submission for inclusion of data into the label in Q4 2019.

"We're continuing to engage in discussions with EU and other regulators on how best to take forward this data, but we are determined to try to find a way to reflect the benefits of Entresto in a broader patient population," Narasimhan said.

The company launched a direct-to-consumer advertising campaign for sacubitril/valsartan amid continued concerns about the safety of tainted generic sartans. Earlier this month, the FDA approved a new pediatric indication for the angiotensin receptor neprilysin inhibitor for the treatment of symptomatic HF with systolic dysfunction in children 1 year and older.

Much of the call, however, was focused on another key growth driver, onasemnogene abeparvovec-xioi (Zolgensma), which racked up $160 million in sales in its first full quarter on the market. Approved in May to treat spinal muscular atrophy, the gene therapy is the world's most expensive drug at more than $2 million for a one-time infusion.

The sales came despite the FDA announcing it was investigating AveXis, a Novartis company, for knowingly submitting "manipulated data" in its marketing application for Zolgensma. The agency warned of possible criminal or civil penalties but allowed the drug to remain on the market.

The company remains bullish on Zolgensma despite admitting difficulties in getting patients through the reimbursement process, citing expanded newborn screening and Medicaid policies coming online in key states like Florida, New Jersey, and Michigan.

Although approval of the drug has been delayed in Europe and Japan after regulators raised manufacturing questions, company officials said they anticipate an opinion in Europe in the first quarter of 2020 and a decision in Japan in the first half of 2020.

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