The FDA has given the green light to Danish company Ascendis Pharma for the first slow-release formulation that provides a weekly alternative to daily injections for children with growth hormone deficiency.
For decades, patients with growth hormone deficiency have required tedious daily hormone injections to stave off the effects of the rare condition, including slow growth in children and high levels of body fat in adults. However, the last two years have seen approvals of slow-release formulations that reduce the injection requirement to once a week.
Last year, the FDA approved the first weekly slow-release form of growth hormone in adults with growth hormone deficiency: Novo Nordisk’s Sogroya. An EU approval of Sogroya followed earlier this year.
Then last week, Ascendis Pharma received the FDA’s blessing to market its slow-release hormone therapy Skytrofa for growth hormone deficiency — in this case in children. The Danish company’s stocks have soared by 25% since the approval, and an EU decision is expected later this year.
“Long-acting sustained-release technologies have been the holy grail in the delivery of hormones,
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