Novo Nordisk's Growth Hormone Injection Safety Questioned Over Weekly Dosing

On September 5, China's National Medical Products Administration (CDE) officially accepted Novo Nordisk's market access application for its Parsi growth hormone injection, branded as Sogroya. This injection contains somapacitan, an active ingredient that is a long-acting variant of human growth hormone (hGH). Somapacitan modifies the natural hGH, enhancing its affinity for plasma albumin, which allows for a weekly dosing regimen.

The U.S. Food and Drug Administration (FDA) initially approved somapacitan on September 1, 2020, for treating growth hormone deficiency in adults. By April 2023, the FDA extended its approval to include children aged 2.5 years and older with the same deficiency.

Novo Nordisk has been proactive in expanding the usage of somapacitan. According to data from the Pharmaceutical Rubik's Cube database, the company initiated a Phase III clinical study (CTR20211271) in China in June 2021. This study focused on pediatric patients suffering from slow growth due to insufficient growth hormone secretion. It was completed in January of this year. The main goal was to evaluate the efficacy and safety of administering somapacitan once a week compared to the daily administration of Norditropin in children with growth hormone deficiency in China.

The REAL4 study, another pivotal investigation, provided further positive results. This multicenter, randomized, open-label Phase III clinical trial aimed to assess the efficacy and safety of somapacitan in preadolescent children with growth hormone deficiency. In the REAL4 study, participants were randomized in a 2:1 ratio to receive either a weekly subcutaneous injection of 0.16 mg/kg somapacitan (132 patients) or a daily subcutaneous injection of 0.034 mg/kg Norditropin (68 patients).

The outcomes from the REAL4 study were promising. Patients who received the weekly somapacitan injections had an annualized growth rate of 11.2 cm per year. This was not significantly different from the 11.7 cm per year growth rate observed in patients receiving daily Norditropin injections, thereby meeting the primary endpoint of the study for non-inferior efficacy. Furthermore, somapacitan was well tolerated and displayed a safety and tolerability profile similar to that of Norditropin.

These findings reinforce the potential of somapacitan as an effective and convenient treatment option for growth hormone deficiency, offering a less frequent dosing schedule without compromising efficacy or safety. With the acceptance of Novo Nordisk's market access application in China, the company is poised to make significant strides in improving treatment options for both adult and pediatric patients with growth hormone deficiencies.

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