FDA approves Sogroya (somapacitan-beco) a 0nce-weekly treatment for Adult Growth Hormone Deficiency.
Sogroya (somapacitan-beco) injection 10 mg/1.5 mL (6.7 mg/mL) is a human growth hormone analog taken once a week by subcutaneous injection. The FDA’s decision is based on a comprehensive clinical program, including the REAL 1 study, a 35-week, double-blind, placebo-controlled study, in treatment-naïve adult patients with GHD.
Sogroya may cause serious side effects, including:
- High risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing problems
- Increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer
- New or worsening high blood sugar or diabetes
- Odema
- Decrease in a hormone called cortisol
- Decrease in thyroid hormone levels.
- Severe and constant abdominal pain. This could be a sign of pancreatitis
- Loss of fat and tissue weakness in the area of skin you inject.
- Increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood
The most common side effects of Sogroya may include back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils, vomiting, high blood pressure, increase creatine phosphokinase, weight gain, and low red blood cells
Source: FDA