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Novartis (NVS) Gets FDA Nod for Cosentyx's Label Expansion
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Novartis AG (NVS - Free Report) announced that the FDA has approved Cosentyx (secukinumab) for the treatment of both active enthesitis-related arthritis (“ERA”) in patients aged four years and above and active juvenile psoriatic arthritis (JPsA) in patients aged two years and older.
Following the nod, Cosentyx became the only biologic treatment approved for treating both ERA and PsA in children and adolescents in the United States. This marks the second and third approvals for Cosentyx in a pediatric population. The drug is already approved for treating pediatric psoriasis.
The latest approval was based on data from the phase III JUNIPERA study, which evaluated Cosentyx in children and adolescents aged between two to 18 years who are diagnosed with ERA or JPsA. Data from the same showed that treatment with Cosentyx reduced flare risk compared to placebo and improved disease activity observed over two years for both indications in the pediatric patient population.
Novartis has already filed a regulatory application in Europe seeking approval for Cosentyx in ERA and JPsA. A decision is expected in the upcoming months.
We note that Cosentyx has performed exceptionally well since its approval on continued label expansions and is one of the top revenue generators for Novartis. In the first nine months of 2021, the drug generated sales worth $3.5 billion.
Shares of Novartis have declined 8.6% so far this year against the industry’s growth of 18.7%.
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In a separate press release, Novartis announced that the FDA has approved Leqvio (inclisiran) to reduce low-density lipoprotein cholesterol (LDL-C) with two doses a year.
The drug is indicated in the United States as an adjunct to diet and maximally tolerated statin therapy for treating atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia (HeFH) in adult patients requiring additional lowering of LDL-C.
In December 2020, Novartis received marketing authorization for Leqvio from the European Commission.
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals (ALNY - Free Report) .
Alnylam is entitled to receive tiered royalties on the global sales of Leqvio from Novartis.
Approval of new drugs and label expansion of existing drugs are likely to boost Novartis’ top line in the days to come.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include GlaxoSmithKline plc (GSK - Free Report) and Endo International plc . While GlaxoSmithKline currently holds a Zacks Rank #2 (Buy), Endo International sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
GlaxoSmithKline’s earnings estimates have been revised 8.5% upward for 2021 and 6.2% for 2022 over the past 60 days. The stock has rallied 18.9% year to date.
GlaxoSmithKline’s earnings surpassed estimates in two of the trailing four quarters, missed the same once and matched it once.
Endo International’s earnings estimates have been revised 22.4% upward for 2021 and 9.8% for 2022 over the past 60 days.
Endo International’s earnings surpassed estimates in each of the trailing four quarters.
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Novartis (NVS) Gets FDA Nod for Cosentyx's Label Expansion
Novartis AG (NVS - Free Report) announced that the FDA has approved Cosentyx (secukinumab) for the treatment of both active enthesitis-related arthritis (“ERA”) in patients aged four years and above and active juvenile psoriatic arthritis (JPsA) in patients aged two years and older.
Following the nod, Cosentyx became the only biologic treatment approved for treating both ERA and PsA in children and adolescents in the United States. This marks the second and third approvals for Cosentyx in a pediatric population. The drug is already approved for treating pediatric psoriasis.
The latest approval was based on data from the phase III JUNIPERA study, which evaluated Cosentyx in children and adolescents aged between two to 18 years who are diagnosed with ERA or JPsA. Data from the same showed that treatment with Cosentyx reduced flare risk compared to placebo and improved disease activity observed over two years for both indications in the pediatric patient population.
Novartis has already filed a regulatory application in Europe seeking approval for Cosentyx in ERA and JPsA. A decision is expected in the upcoming months.
We note that Cosentyx has performed exceptionally well since its approval on continued label expansions and is one of the top revenue generators for Novartis. In the first nine months of 2021, the drug generated sales worth $3.5 billion.
Shares of Novartis have declined 8.6% so far this year against the industry’s growth of 18.7%.
In a separate press release, Novartis announced that the FDA has approved Leqvio (inclisiran) to reduce low-density lipoprotein cholesterol (LDL-C) with two doses a year.
The drug is indicated in the United States as an adjunct to diet and maximally tolerated statin therapy for treating atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia (HeFH) in adult patients requiring additional lowering of LDL-C.
In December 2020, Novartis received marketing authorization for Leqvio from the European Commission.
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals (ALNY - Free Report) .
Alnylam is entitled to receive tiered royalties on the global sales of Leqvio from Novartis.
Approval of new drugs and label expansion of existing drugs are likely to boost Novartis’ top line in the days to come.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include GlaxoSmithKline plc (GSK - Free Report) and Endo International plc . While GlaxoSmithKline currently holds a Zacks Rank #2 (Buy), Endo International sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
GlaxoSmithKline’s earnings estimates have been revised 8.5% upward for 2021 and 6.2% for 2022 over the past 60 days. The stock has rallied 18.9% year to date.
GlaxoSmithKline’s earnings surpassed estimates in two of the trailing four quarters, missed the same once and matched it once.
Endo International’s earnings estimates have been revised 22.4% upward for 2021 and 9.8% for 2022 over the past 60 days.
Endo International’s earnings surpassed estimates in each of the trailing four quarters.