FDA Rejects Growth Hormone Deficiency Drug

Despite undergoing clinical development, many drugs never receive approval from the FDA. Recently, this happened to a treatment for growth hormone deficiency (GHD). The medication, titled somatrogon and owned by Pfzier, is administered via pre-filled injection once a week. While we are unsure of the reasoning behind this rejection, Pfizer has stated that they will collaborate with the FDA to move forward.

About the Rejection

Pfizer announced the FDA’s decision last week but did not disclose the specific reasons driving the rejection. While somatrogon will not move forward – at least, not right now – there are other options for children with GHD.

One of these options is Skytrofa, which is also a weekly injection. Skytrofa received approval in the United States last August, with approval in Europe coming the following January. Beyond this option, Pfizer actually offers another GHD treatment: Genotropin. The difference with this drug is that is administered once a day.

Turning back to somatrogon, Pfizer is not abandoning this product. In fact, it has already been approved in other countries: Japan, Australia, and Canada. The pharmaceutical company expects a decision from Europe soon as well. Along with these developments, Pfizer will work with the FDA in order to progress towards approval.

About GHD

As the name suggests, growth hormone deficiency (GHD) occurs when the body makes insufficient amounts of growth hormone. When there isn’t enough of this hormone, the body is unable to grow at a normal rate, resulting in short stature. Other symptoms include:

  • Fine hair
  • Poor nail growth
  • Stunted growth
  • Hypoglycemia (this symptom is present in newborns)
  • High pitched voice
  • Small genitals (this symptom is present in males)
  • Immature appearance
  • “Chubby” build
  • Slow tooth eruption
  • Prominent forehead

These symptoms are all the result of too little growth hormone, which can be caused by many different things. These include genetic mutations (the POU1F1/Pit1, PROP1, GHRH and GH1 genes have all been connected to GHD), brain trauma, radiation therapy, infection, and brain tumors. GHD is treated by injecting more of the growth hormone into affected individuals.

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