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Novo (NVO) Gets CRL From FDA for Weekly Basal Insulin Icodec
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Novo Nordisk (NVO - Free Report) announced that it has received a complete response letter from the FDA for its biologics license application (“BLA”) for once-weekly basal insulin icodec.
The BLA seeks approval for once-weekly basal insulin icodec for the treatment of diabetes mellitus. The application was submitted in April 2023.
The FDA requested information related to the manufacturing process and the type 1 diabetes indication before it can complete the review of the application.
Novo is evaluating the content of the CRL and will work closely with the FDA to fulfill the requests.
An FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting was convened in May 2024 with a panel of independent scientific experts to discuss the benefit-risk of once-weekly basal insulin icodec in type 1 diabetes. The panel determined that the data available were not sufficient to conclude on a positive benefit-risk in type 1 diabetes. The Advisory Committee did not discuss the use of once-weekly insulin icodec in type 2 diabetes.
Please note that insulin icodec is already approved under the brand name Awiqli in the EU, Canada, Australia, Japan and Switzerland for the treatment of both type 1 and type 2 diabetes and in China for type 2 diabetes.
Year to date, shares of NVO have jumped 38% compared with the industry’s 21.8% growth.
Image Source: Zacks Investment Research
The stupendous performance that the stock was witnessing earlier on in the year due to exemplary growth of its obesity drug Wegovy (semaglutide) has somewhat been offset by a few setbacks in recent times.
Semaglutide is marketed as Wegovy and Ozempic for obesity and diabetes, respectively.
Earlier in the week, data from a new study showed that patients who received Eli Lilly’s (LLY - Free Report) obesity drug Mounjaro (tirzepatide) significantly lost more weight than those who received Wegovy.
While both medications were shown to be effective in achieving weight loss, findings indicate that Mounjaro may be more beneficial. After three months, patients taking the Lilly drug lost an average of 5.9% of their body weight compared with 3.6% for those on Wegovy. This trend also continued at six and 12 months, with Mounjaro users achieving an average weight loss of 10.1% and 15.3%, respectively, versus 5.8% and 8.3% for Wegovy users.
The data also showed that patients taking Lilly’s drug were more likely to reach weight loss milestones.
Last week, shares of both NVO and LLY slipped after a study showed that patients who received Novo semaglutide could develop a rare blinding eye disorder.
The study, which investigators led from a Harvard-affiliated teaching hospital, showed that patients who were prescribed semaglutide were at a higher risk of developing non-arteritic anterior ischemic optic neuropathy than those taking other diabetes or weight loss drugs. This condition restricts blood flow to the optic nerve and can cause permanent blindness.
Shares of both companies took a beating after President Joe Biden and Senator Bernie Sanders called out Novo and Eli Lilly for the ‘unconscionably high’ prices of their weight-loss drugs.
Entrada’s loss per share estimate for 2024 has narrowed from 27 cents to 13 cents in the past 60 days. The same for 2025 has narrowed from $3.44 to $3.21 in the past 30 days.
In the past 60 days, estimates for CORT’s 2024 earnings per share have improved from 90 to 95 cents. Shares of CORT have rallied 24.5% in the past three months.
CORT’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 33.7%.
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Novo (NVO) Gets CRL From FDA for Weekly Basal Insulin Icodec
Novo Nordisk (NVO - Free Report) announced that it has received a complete response letter from the FDA for its biologics license application (“BLA”) for once-weekly basal insulin icodec.
The BLA seeks approval for once-weekly basal insulin icodec for the treatment of diabetes mellitus. The application was submitted in April 2023.
The FDA requested information related to the manufacturing process and the type 1 diabetes indication before it can complete the review of the application.
Novo is evaluating the content of the CRL and will work closely with the FDA to fulfill the requests.
An FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting was convened in May 2024 with a panel of independent scientific experts to discuss the benefit-risk of once-weekly basal insulin icodec in type 1 diabetes. The panel determined that the data available were not sufficient to conclude on a positive benefit-risk in type 1 diabetes. The Advisory Committee did not discuss the use of once-weekly insulin icodec in type 2 diabetes.
Please note that insulin icodec is already approved under the brand name Awiqli in the EU, Canada, Australia, Japan and Switzerland for the treatment of both type 1 and type 2 diabetes and in China for type 2 diabetes.
Year to date, shares of NVO have jumped 38% compared with the industry’s 21.8% growth.
Image Source: Zacks Investment Research
The stupendous performance that the stock was witnessing earlier on in the year due to exemplary growth of its obesity drug Wegovy (semaglutide) has somewhat been offset by a few setbacks in recent times.
Semaglutide is marketed as Wegovy and Ozempic for obesity and diabetes, respectively.
Earlier in the week, data from a new study showed that patients who received Eli Lilly’s (LLY - Free Report) obesity drug Mounjaro (tirzepatide) significantly lost more weight than those who received Wegovy.
While both medications were shown to be effective in achieving weight loss, findings indicate that Mounjaro may be more beneficial. After three months, patients taking the Lilly drug lost an average of 5.9% of their body weight compared with 3.6% for those on Wegovy. This trend also continued at six and 12 months, with Mounjaro users achieving an average weight loss of 10.1% and 15.3%, respectively, versus 5.8% and 8.3% for Wegovy users.
The data also showed that patients taking Lilly’s drug were more likely to reach weight loss milestones.
Last week, shares of both NVO and LLY slipped after a study showed that patients who received Novo semaglutide could develop a rare blinding eye disorder.
The study, which investigators led from a Harvard-affiliated teaching hospital, showed that patients who were prescribed semaglutide were at a higher risk of developing non-arteritic anterior ischemic optic neuropathy than those taking other diabetes or weight loss drugs. This condition restricts blood flow to the optic nerve and can cause permanent blindness.
Shares of both companies took a beating after President Joe Biden and Senator Bernie Sanders called out Novo and Eli Lilly for the ‘unconscionably high’ prices of their weight-loss drugs.
Zacks Rank and Stocks to Consider
Novo currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the healthcare sector are Entrada Therapeutics (TRDA - Free Report) and Corcept Therapeutics (CORT - Free Report) , both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s loss per share estimate for 2024 has narrowed from 27 cents to 13 cents in the past 60 days. The same for 2025 has narrowed from $3.44 to $3.21 in the past 30 days.
In the past 60 days, estimates for CORT’s 2024 earnings per share have improved from 90 to 95 cents. Shares of CORT have rallied 24.5% in the past three months.
CORT’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 33.7%.