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February 16, 2022

EC grants marketing authorisation for Pfizer-OPKO’s Ngenla injection

The authorisation is based on data from a Phase III trial where Ngenla was found to be non-inferior to Genotropin.

The European Commission (EC) has granted marketing authorisation for Pfizer and OPKO Health’s Ngenla (somatrogon) injection for the treatment of children and adolescents aged three years and above with growth hormone deficiency (GHD). 

Once a week injection of Ngenla is intended to treat growth disturbance owing to inadequate growth hormone secretion.

The authorisation builds on the data obtained from a randomised, international, open-label, active-controlled Phase III clinical trial of Ngenla.

It analysed the safety and efficacy of the injection administered once a week versus a once-daily dose of Genotropin (somatropin).

The trial met the primary endpoint where Ngenla demonstrated to be non-inferior compared to Genotropin, as analysed by annual height velocity at one year. 

Furthermore, in the trial, Ngenla was found to be well tolerated with a safety profile in line with Genotropin.

The latest development permits the use of Ngenla in all Member States of the EU and in Norway Iceland and Liechtenstein.

Pfizer Rare Disease International Developed Markets regional president Reda Guiha said: “Growth hormone deficiency takes a substantial toll on children living with this rare disease and their families, and for many years, daily injections have been the standard of care, adding to the challenges they face. 

“With Ngenla, we are proud to continue to advance the care of children in Europe who are impacted by growth hormone deficiency with a new, longer-acting option that significantly reduces treatment burden from once-daily to once-weekly injections.”

A synthetic, long-acting recombinant human growth hormone, Ngenla acts by replacing the growth hormone deficiency in the body. 

Pfizer and OPKO signed a global agreement in 2014 to develop and market Ngenla to treat GHD, a rare disease caused by the insufficient pituitary gland secretion of somatropin, a growth hormone. 

In January, the US Food and Drug Administration (FDA) issued a complete response letter to the biologics license application submitted by the companies for somatrogon to treat paediatric GHD.

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