CHMP positive recommendation for Somatrogon, a long-acting treatment for pediatric growth hormone deficiency. -Pfizer + OPKO Health

A decision from the European Commission (EC) is expected in early 2022.

GHD is a rare disease characterized by the inadequate secretion of growth hormone, and affects one in approximately 4,000 to 10,000 children worldwide. Without treatment, affected children will have persistent growth attenuation and a very short height in adulthood. Children may also experience other problems with physical health and mental well-being.

The recommendation for somatrogon is based on the results from a global, Phase III randomized, open-label, active controlled study which evaluated the safety and efficacy of once-weekly somatrogon compared to Genotropin (somatropin) for injection administered once-daily. This study met its primary endpoint of somatrogon non-inferiority compared to Genotropin (somatropin) for injection administered once daily, as measured by annual height velocity at 12 months.

“Daily injections are often challenging for those impacted by pediatric growth hormone deficiency. Children may object to receiving a shot every day and caregivers may feel strains on their relationships,” said Jamie Harvey, CEO of the International Coalition of Organizations Supporting Endocrine Patients (ICOSEP). “At ICOSEP, we understand these challenges and are hopeful that if somatrogon receives marketing authorization in the European Union, this once-weekly treatment option may help children living with growth hormone deficiency reach their full potential.” .