EMA Panel Backs Weekly Hormone for Child Growth Disorders
The European Medicines Agency's panel has recommended expanding the use of a weekly growth hormone treatment for children with specific growth disorders. This treatment, Sogroya, could significantly reduce the frequency of injections needed for affected children. The positive opinion follows clinical trials demonstrating its efficacy in improving height velocity in children born small for gestational age and those with Noonan syndrome.
- ▪Sogroya is a long-acting growth hormone derivative that allows for once-weekly administration instead of daily injections.
- ▪The EMA's recommendation is based on clinical evidence showing superior height velocity outcomes compared to daily growth hormone treatments.
- ▪Common side effects of Sogroya include headache, hypothyroidism, and reactions at the injection site.
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Long-acting once-weekly growth hormone treatment has moved closer to expanded use in Europe for two new pediatric indications, potentially reducing injection frequency for children with specific growth disorders. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the expansion of approved indications for Sogroya (somapacitan, Novo Nordisk) for growth disturbances in children born small for gestational age (SGA) and for children with Noonan syndrome, in addition to its existing pediatric indication for growth hormone deficiency.Who Qualifies for Treatment For SGA patients, the indication covers children with current height standard deviation score (SDS) below -2.5 and parental adjusted height SDS below -1, who…
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