DTMT Network

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending somatrogon, a once-weekly long-acting recombinant human growth hormone, for marketing authorisation to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone, Pfizer announced.

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

“The CHMP’s positive opinion of somatrogon is an important milestone in our efforts to deliver therapeutic options that can help children reach their full potential,” said Brenda Cooperstone, M.D., Chief Development Officer, Rare Disease, Pfizer Global Product Development said.

“For decades, Pfizer has been committed to improving the lives of those impacted by growth hormone deficiency and we look forward to working closely with the European Commission to hopefully soon provide a once-weekly treatment option for the pediatric growth hormone deficiency (GHD) community in the European Union,” she added.

GHD is a rare disease where the secretion of growth hormone remains inadequate, and affects one in approximately 4,000 to 10,000 children worldwide, the announcement added.

Without treatment, affected children will have persistent growth attenuation and a very short height in adulthood and children may also experience other problems with physical health and mental well-being, Pfizer said.

The recommendation for somatrogon comes after the results from a global, Phase 3 randomised, open-label, active-controlled study which evaluated the safety and efficacy of once-weekly somatrogon compared to GENOTROPIN® (somatropin) for injection administered once-daily, the company informed.

According to Pfizer, the study has established that once a week administration of somatrogon injection was not found inferior when compared to once a day administered somatropin injection, which was the primary objective of the trial.

“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,” Jamie Harvey, CEO of the International Coalition of Organisations Supporting Endocrine Patients (ICOSEP) said.

“At ICOSEP, we understand these challenges and are hopeful that if somatrogon receives marketing authorisation in the European Union, this once-weekly treatment option may help children living with growth hormone deficiency reach their full potential, she added.”

If approved by the European Commission, somatrogon will offer children and adolescents living with GHD a once-weekly treatment option resulting in fewer doses per year compared to daily treatment options, Pfizer said.