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Novartis (NVS) Announces Positive Long-Term Data on Leqvio
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Novartis (NVS - Free Report) announced new long-term data on the cholesterol-lowering drug Leqvio at the European Society of Cardiology (“ESC”) Congress 2023 in Amsterdam.
Leqvio is the first and only small interfering RNA therapy to lower LDL-C. The drug is approved in various countries, including the United States, the EU and China.
Results from the ORION-8 open-label extension study showed that twice-yearly Leqvio, in addition to statin therapy, provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six years of treatment in patients with atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolemia.
ORION-8 is a three-year open-label extension of the placebo-controlled 18-month phase III trials ORION-9, ORION-10, and ORION-11 and the four-year phase II ORION-3 trial. Patients from ORION-9, ORION-10, ORION-11 and ORION-3 received Leqvio every six months for up to an additional three years. Data showed that nearly 80% of patients reached their pre-specified LDL-C targets, and on average, LDL-C levels were reduced by approximately 50%.
Data supports the consistent long-term efficacy, safety and tolerability of Leqvio, with a total exposure of more than 8,500 patient-years during the study’s follow-up. ORION-8 is part of the VictORION trial program that is examining the use of Leqvio in broad and varied patient populations affected by ASCVD.
Many patients do not reach their recommended LDL-C target through the use of statin therapy alone, even though LDL-C is one of the most readily modifiable risk factors for heart disease. Such patients can benefit from Leqvio, given the demonstrated long-term efficacy. Further, both the patient and the healthcare provider can be confident that a dose has been received for six months after administration.
We note that Novartis owns the global right to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.
Shares of Novartis have risen 12.8% year to date compared with the industry’s 7.5% growth.
Image Source: Zacks Investment Research
Leqvio was launched in January 2022 in the United States. The FDA approved a label update of the drug in July 2023 that allows for the earlier use of Leqvio to help reduce LDL-C as an adjunct to diet and statin therapy for patients with elevated LDL-C who did not have a cardiovascular event but are at an increased risk of heart disease.
Leqvio, a subcutaneous injection given by a healthcare provider with an initial dose, another at three months and then every six months, was added to NVS’ portfolio following the acquisition of The Medicines Company.
As a twice-yearly and professionally administered treatment, Leqvio is expected to enable patients to face the challenges of treatment adherence, a common issue in cholesterol management. Novartis had identified Leqvio as one of the top six sales growth drivers. Hence, positive long-term data from the drug reinforces its potential, which should eventually boost sales.
Sales of the drug came in at $142 million in the first half of 2023 as the launch progressed in the United States and other markets. The less-frequent dosing schedule compared to established drugs like Repatha and Praluent works in favor of Leqvio.
With the planned spin-off of Sandoz, Novartis is looking to become a pure-play pharmaceutical company. The strong performance of key drugs, strategic acquisitions and a streamlined focus should pave the way for solid growth for NVS in the quarters ahead.
Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Estimates for SPRO’s 2023 loss have narrowed by 39 cents to 51 cents per share in the past 30 days. Spero’s earnings beat estimates in all the trailing four quarters, the average surprise being 72.43%.
Estimates for DVAX’s 2023 loss have narrowed by 27 cents to 24 cents per share in the past 30 days. Dynavax has risen 36.2% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.
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Novartis (NVS) Announces Positive Long-Term Data on Leqvio
Novartis (NVS - Free Report) announced new long-term data on the cholesterol-lowering drug Leqvio at the European Society of Cardiology (“ESC”) Congress 2023 in Amsterdam.
Leqvio is the first and only small interfering RNA therapy to lower LDL-C. The drug is approved in various countries, including the United States, the EU and China.
Results from the ORION-8 open-label extension study showed that twice-yearly Leqvio, in addition to statin therapy, provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six years of treatment in patients with atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolemia.
ORION-8 is a three-year open-label extension of the placebo-controlled 18-month phase III trials ORION-9, ORION-10, and ORION-11 and the four-year phase II ORION-3 trial. Patients from ORION-9, ORION-10, ORION-11 and ORION-3 received Leqvio every six months for up to an additional three years. Data showed that nearly 80% of patients reached their pre-specified LDL-C targets, and on average, LDL-C levels were reduced by approximately 50%.
Data supports the consistent long-term efficacy, safety and tolerability of Leqvio, with a total exposure of more than 8,500 patient-years during the study’s follow-up. ORION-8 is part of the VictORION trial program that is examining the use of Leqvio in broad and varied patient populations affected by ASCVD.
Many patients do not reach their recommended LDL-C target through the use of statin therapy alone, even though LDL-C is one of the most readily modifiable risk factors for heart disease. Such patients can benefit from Leqvio, given the demonstrated long-term efficacy. Further, both the patient and the healthcare provider can be confident that a dose has been received for six months after administration.
We note that Novartis owns the global right to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.
Shares of Novartis have risen 12.8% year to date compared with the industry’s 7.5% growth.
Image Source: Zacks Investment Research
Leqvio was launched in January 2022 in the United States. The FDA approved a label update of the drug in July 2023 that allows for the earlier use of Leqvio to help reduce LDL-C as an adjunct to diet and statin therapy for patients with elevated LDL-C who did not have a cardiovascular event but are at an increased risk of heart disease.
Leqvio, a subcutaneous injection given by a healthcare provider with an initial dose, another at three months and then every six months, was added to NVS’ portfolio following the acquisition of The Medicines Company.
As a twice-yearly and professionally administered treatment, Leqvio is expected to enable patients to face the challenges of treatment adherence, a common issue in cholesterol management. Novartis had identified Leqvio as one of the top six sales growth drivers. Hence, positive long-term data from the drug reinforces its potential, which should eventually boost sales.
Sales of the drug came in at $142 million in the first half of 2023 as the launch progressed in the United States and other markets. The less-frequent dosing schedule compared to established drugs like Repatha and Praluent works in favor of Leqvio.
With the planned spin-off of Sandoz, Novartis is looking to become a pure-play pharmaceutical company. The strong performance of key drugs, strategic acquisitions and a streamlined focus should pave the way for solid growth for NVS in the quarters ahead.
Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - Free Report) . While Spero sports a Zacks Rank #1 (Strong Buy) at present, Dynavax carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for SPRO’s 2023 loss have narrowed by 39 cents to 51 cents per share in the past 30 days. Spero’s earnings beat estimates in all the trailing four quarters, the average surprise being 72.43%.
Estimates for DVAX’s 2023 loss have narrowed by 27 cents to 24 cents per share in the past 30 days. Dynavax has risen 36.2% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.