After Eli Lilly and Boehringer Ingelheim posted a landmark win for their diabetes drug Jardiance in heart failure patients with preserved ejection fraction earlier this month, the pressure is naturally on for Novartis’ blockbuster Entresto. But to hear a Novartis exec tell it, the company isn’t scared of the competition.
Entresto has a “unique position” thanks to its broad label that covers 5 out of 6 U.S. patients with chronic heart failure, Novartis’ pharma chief Marie-France Tschudin told investors during a conference call Wednesday. The medicine is “very strong with the cardiologists,” she added.
“Between the compelling data, the strong guidelines’ support that we have, the commercial infrastructure, the excellent team we have in place, we have what it takes to continue the momentum of Entresto,” Tschudin said.
In February, Entresto landed the much-coveted FDA go-ahead to expand its reach to treat heart failure with preserved ejection fraction (HFpEF) for patients whose left ventricular ejection fraction is below normal. The nod made Entresto the first med approved for both chronic heart failure with reduced ejection fraction (HFrEF) and HFpEF.
Sales quickly spiked as the new label opened up a large new pool of patients. In the second quarter, Entresto sales increased 46% year over year at constant currencies to $886 million. The U.S. haul, at $481 million, jumped 63% as weekly new-to-brand scripts reached around 6,500, compared with about 4,600 in March 2020 before the COVID-19 slowdown, Tschudin showed.
Plus, the American College of Cardiology's recent updated recommendation for Entresto in HFrEF is also driving demand. Meanwhile, the drug has tripled sales in China as a result of “strategic account expansion,” making the country now Entresto’s second-biggest market behind the U.S., Tschudin said.
Still, Entresto’s U.S. label doesn’t include all HFpEF patients. That's because in its phase 3 trial, the drug didn’t offer enough benefits in terms of reducing cardiovascular-related events among HFpEF patients with higher ejection fractions.
Jardiance didn’t appear to have that limitation in its own study. In Lilly and Boehringer’s headline announcement two weeks ago, the pair said Jardiance reduced the risk of death and hospitalization from heart failure in HFpEF patients, period. This means Jardiance could potentially treat all heart failure patients regardless of their ejection fraction score. And given that AstraZeneca’s fellow SGLT2 diabetes drug Farxiga and Johnson & Johnson Invokana have also offered benefits in other heart failure settings, the potential of a classwide benefit could further threaten Entresto.
Tschudin said Novartis wants to see the full data from the Jardiance trial because its design was different from Entresto’s. Lilly and Boehringer plan to detail their findings at the European Society of Cardiology Congress in late August.
Outside Entresto, Novartis' immunology drug Cosentyx posted a 21% sales increase at constant exchange rates to $1.2 billion in the second quarter. Cosentyx’s U.S. field force activity is now above pre-COVID levels, and the drug quadrupled sales in China over the first quarter after its inclusion in the country’s National Reimbursement Drug list, Tschudin said.
Novartis’ pricey gene therapy Zolgensma is on track to cross the blockbuster threshold this year. The spinal muscular atrophy drug brought in $315 million in second-quarter sales, bringing the first-half tally to $634 million.
Aside from those meds, the Swiss pharma is trying to get its cholesterol drug inclisiran—approved in EU under the brand Leqvio—across the FDA finish line after a rejection related to manufacturing inspection concerns at a third-party site in Italy. To overcome the problem, Novartis has refiled the drug instead with an in-house manufacturing site in Austria.
While the FDA has assigned a new action date for Jan. 1, 2022, Novartis can’t predict whether the FDA will require another inspection, CEO Vas Narasimhan said on Wednesday’s call. But he did note that the site is “regularly inspected,” and the particular production line the company earmarked for Leqvio has recently been inspected by the FDA remotely and approved for use for another drug.