Novo Nordisk NVO announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended label expansion for the once-weekly growth hormone drug Sogroya (somapacitan).
The CHMP granted positive opinion to Sogroya for the replacement of endogenous growth hormone in children aged three years and above, and adolescents with growth failure due to growth hormone deficiency, based on data from the phase III REAL4 study.
The study results showed that the once-weekly subcutaneous injection of Sogroya worked as well as a daily injection of Norditropin (somatropin) for this indication. At the end of the trial period, prepubertal children who were treated with once-weekly Sogroya achieved similar growth as children who were treated with once-daily Norditropin.
Growth hormone deficiency in children starts early and results in short stature as well as other growth-related health problems.
The European Commission takes into consideration the CHMP’s positive opinion but is not bound by it.
Sogroya was approved in the EU in 2021 for the replacement of endogenous growth hormone in adults with growth hormone deficiency (AGHD). The drug was also granted approval in the United States in April 2023.
Shares of Novo Nordisk have gained 20.3% in the year so far against the industry’s decline of 0.6%.
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Novo Nordisk has been in the news this week. Shares were down on May 23, following the publication of encouraging data on Pfizer’s PFE investigational drug danuglipron for the treatment of type 2 diabetes and obesity in the JAMA Network medical journal. In a phase II randomized clinical study in 411 adults with type 2 diabetes, danuglipron reduced glycated hemoglobin, fasting plasma glucose (at all doses) and body weight (at the highest doses) at week 16 compared with placebo.
Investors were impressed, as the weight loss observed with danuglipron is of a similar magnitude to that observed in the phase II data for oral semaglutide. Consequently, Pfizer’s shares were up, but Novo Nordisk’s shares were down, as the successful development of danuglipron will pose competition to Novo Nordisk’s obesity care drugs.
Novo Nordisk’s injectable semaglutide 2.4 mg is already approved under the brand name Wegovy for obesity.
The company also announced positive results from a phase IIIa study, OASIS 1, in the global OASIS program for a once-daily oral formulation of semaglutide in obesity. The study achieved its primary endpoint, with people showing statistically significant and superior weight loss at week 68 with oral semaglutide 50 mg compared with placebo.
NVO also has another approved drug, Saxenda (liraglutide), for obesity care.
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the healthcare sector are Novartis NVS and Ligand Pharmaceuticals LGND. LGND currently sports a Zacks Rank #1 (Strong Buy) and Novartis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by 63 cents to $4.79. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 30 days, NVS’ earnings estimates have increased to $6.67 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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