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FDA Issues Complete Response Letter (CRL) for Somatrogon for Growth Hormone Deficiency (GHD)

 Last Update: 2022-02-18
 Source: Internet
 Author: User

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Pfizer and its partner OPKO Health today announced that the FDA has issued a Complete Response Letter (CRL) for Somatrogon, an investigational once-weekly growth hormone deficiency (GHD) therapy
.

FDA

Growth hormone deficiency (GHD) is a rare but treatable growth disorder in children
that can occur alone or in combination with other anterior and/or posterior pituitary hormone deficiencies .

In 2020, the prevalence of GHD diagnoses in seven major markets (US, France, Germany, Spain, Italy, UK and Japan) was only 0.

Diagnosis of children

For decades, the standard of care for GHD has been daily injections of recombinant human GH, although this regimen has been associated with poor adherence to treatment and poor treatment outcomes
.

This has prompted drug developers to invest in the development of long-acting GH formulations that require less frequent dosing

The application was supported by a Phase III trial that enrolled a total of 224 subjects randomized 1:1 to receive either weekly Somatrogon hGH-CTP (0.
66 mg/kg) or once-daily Genotropin (0.
24 mg/kg) mg/kg/wk) for 12 months
.

The primary endpoint of the study was height velocity (HV) at 12 months

First-line results from the pivotal Phase III trial showed that weekly Somatrogon (hGH-CTP) administered subcutaneously was non-inferior to once-daily Genotropin (hGH)
.

First-line results from the pivotal Phase III trial showed that weekly Somatrogon (hGH-CTP) administered subcutaneously was non-inferior to once-daily Genotropin (hGH)

Original source:

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