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Novo Nordisk (NVO) Gets Positive CHMP Opinion for Insulin Icodec
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Novo Nordisk (NVO - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending marketing authorization for once-weekly basal insulin icodec for the treatment of diabetes in adults. The basal insulin has been recommended under the brand name Awiqli.
The positive CHMP opinion is based on results from the phase IIIa ONWARDS program. The program comprised six phase IIIa global clinical trials, which investigated the efficacy and safety of once-weekly basal insulin icodec, involving more than 4,000 adults with type 1 or type 2 diabetes, including a trial with real-world elements.
Results showed that once-weekly basal insulin icodec achieved superior blood sugar reduction (measured by a change in HbA) and superior time in range (time spent within recommended blood sugar range) vis-à-vis daily basal insulin in type 2 diabetes people.
The observed rates of clinically significant or severe hypoglycemia on an overall basis were below one event per patient-year of exposure with both once-weekly basal insulin icodec and comparators in people with type 2 diabetes who have not previously been treated with insulin. Once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA with a statistically significant higher estimated rate of severe or clinically significant hypoglycemia compared with insulin degludec.
A final marketing authorization from the European Commission is expected within approximately two months. The approval of additional diabetic treatments will further strengthen NVO’s already strong diabetes portfolio.
Novo Nordisk has improved the global diabetes value market share over the last 12 months to 33.8% from 31.9%. The market share increase was driven by market share gains in both North America operations and international operations.
In January 2024, Novo Nordisk successfully completed the first phase IIIa study with IcoSema, a fixed-ratio once-weekly combination of basal insulin icodec and semaglutide and a phase I study with oral amycretin.
In December 2023, the FDA informed Novo Nordisk that data submitted during the regulatory review is considered to constitute a major amendment to the biologics license application (BLA) for insulin icodec. Consequently, the regulatory review is extended by three months to provide time for a full review of the submission. The company expects the review to be completed in the third quarter of 2024.
Shares of Novo Nordisk have rallied 71.9% in the past year compared with the industry’s 30.1% growth. The rally was majorly fueled by NVO’s obesity drug Wegovy (semaglutide 2.4 mg). The drug received FDA approval in 2021 and has been witnessing solid uptake ever since, driven by increasing demand worldwide.
Image Source: Zacks Investment Research
Earlier in the month, NVO announced that the FDA approved its supplemental new drug application seeking label expansion for Wegovy to reduce the risks of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack or stroke in adults with either overweight or obesity and established cardiovascular disease.
In 2023, Wegovy generated sales worth DKK 31.3 billion, representing year-over-year growth of 407% on a reported basis and 420% at a constant exchange rate.
Novo Nordisk A/S Price, Consensus and EPS Surprise
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 to 30 cents. In the past year, shares of ADMA have rallied 107.4%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.
In the past 60 days, loss estimates for GLPG have narrowed from $1.68 per share to 39 cents. Galapagos beat on earnings in three of the trailing four quarters and missed once, delivering an average surprise of 91.97%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have surged 85.2%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.
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Novo Nordisk (NVO) Gets Positive CHMP Opinion for Insulin Icodec
Novo Nordisk (NVO - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending marketing authorization for once-weekly basal insulin icodec for the treatment of diabetes in adults. The basal insulin has been recommended under the brand name Awiqli.
The positive CHMP opinion is based on results from the phase IIIa ONWARDS program. The program comprised six phase IIIa global clinical trials, which investigated the efficacy and safety of once-weekly basal insulin icodec, involving more than 4,000 adults with type 1 or type 2 diabetes, including a trial with real-world elements.
Results showed that once-weekly basal insulin icodec achieved superior blood sugar reduction (measured by a change in HbA) and superior time in range (time spent within recommended blood sugar range) vis-à-vis daily basal insulin in type 2 diabetes people.
The observed rates of clinically significant or severe hypoglycemia on an overall basis were below one event per patient-year of exposure with both once-weekly basal insulin icodec and comparators in people with type 2 diabetes who have not previously been treated with insulin. Once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA with a statistically significant higher estimated rate of severe or clinically significant hypoglycemia compared with insulin degludec.
A final marketing authorization from the European Commission is expected within approximately two months. The approval of additional diabetic treatments will further strengthen NVO’s already strong diabetes portfolio.
Novo Nordisk has improved the global diabetes value market share over the last 12 months to 33.8% from 31.9%. The market share increase was driven by market share gains in both North America operations and international operations.
In January 2024, Novo Nordisk successfully completed the first phase IIIa study with IcoSema, a fixed-ratio once-weekly combination of basal insulin icodec and semaglutide and a phase I study with oral amycretin.
In December 2023, the FDA informed Novo Nordisk that data submitted during the regulatory review is considered to constitute a major amendment to the biologics license application (BLA) for insulin icodec. Consequently, the regulatory review is extended by three months to provide time for a full review of the submission. The company expects the review to be completed in the third quarter of 2024.
Shares of Novo Nordisk have rallied 71.9% in the past year compared with the industry’s 30.1% growth. The rally was majorly fueled by NVO’s obesity drug Wegovy (semaglutide 2.4 mg). The drug received FDA approval in 2021 and has been witnessing solid uptake ever since, driven by increasing demand worldwide.
Image Source: Zacks Investment Research
Earlier in the month, NVO announced that the FDA approved its supplemental new drug application seeking label expansion for Wegovy to reduce the risks of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack or stroke in adults with either overweight or obesity and established cardiovascular disease.
In 2023, Wegovy generated sales worth DKK 31.3 billion, representing year-over-year growth of 407% on a reported basis and 420% at a constant exchange rate.
Novo Nordisk A/S Price, Consensus and EPS Surprise
Novo Nordisk A/S price-consensus-eps-surprise-chart | Novo Nordisk A/S Quote
Zacks Rank and Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Galapagos (GLPG - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 to 30 cents. In the past year, shares of ADMA have rallied 107.4%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.
In the past 60 days, loss estimates for GLPG have narrowed from $1.68 per share to 39 cents. Galapagos beat on earnings in three of the trailing four quarters and missed once, delivering an average surprise of 91.97%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have surged 85.2%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.