EMA validates Pfizer and OPKO’s somatrogon marketing application for review

The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.

Somatrogon is a long-acting human growth hormone (hGH) molecule, which is intended to be injected once-weekly for the treatment of paediatric patients with growth hormone deficiency (GHD).

GHD is a rare disease which is identified by the inadequate secretion of growth hormone from the pituitary gland and affects one in about 4,000 to 10,000 people.

The molecule consists of the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) of the human chorionic gonadotropin hormone.

Pfizer Global Product Development Rare Disease chief development officer Brenda Cooperstone said: “If approved in the EU, somatrogon will represent an important advancement, as this long-acting, weekly treatment may reduce the burden of daily injections on children, their loved ones, and caregivers.

“We look forward to continuing to work with the EMA to evolve the treatment paradigm for pediatric patients with growth hormone deficiency.”

The latest MAA submission is supported by the results of Phase III safety and efficacy evaluation of somatrogon injectable once-weekly to paediatric patients with GHD.

The randomised, open-label, active-controlled study was conducted in more than 20 countries.

If approved by European Commission, which is expected in 2022, somatrogon will serve as a once-weekly treatment option for GHD.

The company noted that somatrogon was well tolerated during the study compared to that of GENOTROPIN (somatropin) injected once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.

Pfizer and OPKO signed a worldwide agreement in 2014 to develop and commercialise somatrogon.

OPKO agreed to conduct the clinical programme and Pfizer is responsible for registering and commercialising the product.