EMA’s CHMP adopts positive opinion for Pfizer’s and OPKO’s somatrogon for GHD treatment

A once-weekly long-acting recombinant human growth hormone, somatrogon is intended for treating children from three years of age and adolescents experiencing growth disturbance because of inadequate secretion of growth hormone.

In 2014, Pfizer and OPKO Health signed a worldwide agreement to develop and commercialise somatrogon to treat growth harmone deficiency.

As per the agreement, OPKO is responsible for undertaking the clinical program, while Pfizer will register and commercialise somatrogon for GHD.

European Commission (EC) is expected to take a decision in early 2022.

Pfizer global product development chief development officer for rare disease Brenda Cooperstone said: “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.

“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.”

A rare disease, GHD is caused due to the inadequate secretion of growth hormone, and impacts one in around 4,000 to 10,000 children across the world.

If not treated, affected children will experience growth attenuation and a very short height in adulthood.

The CHMP recommendation for the drug is based on the results from a global, Phase 3 randomized, open-label, active controlled trial.

This study analysed the safety and efficacy of once-weekly somatrogon as against GENOTROPIN (somatropin) for injection administered once-daily.