FDA Approval Broadens Patient Population for Long-Acting Growth Hormone Sogroya

The FDA recently approved an expanded patient population for Novo Nordisk’s Sogroya (somapacitan-beco), a long-acting growth hormone requiring weekly administration, as opposed to daily administration of short-acting agents. Payers and endocrinologists have expressed a willingness to manage and prescribe the new agents, according to Zitter Insights. Nevertheless, this is a class where agents have not shown clinical differentiation, so payer coverage of the agents likely will come down to cost, industry experts say.

On April 28, the FDA expanded the patient population for Sogroya to include the treatment of people at least 2 1/2 years old who have growth failure due to inadequate secretion of endogenous growth hormone. The agency initially approved the drug on Aug. 28, 2020, for the replacement of growth hormone in adults with growth hormone deficiency. With the newest approval, the injectable becomes the first and only once-weekly growth hormone treatment for both children and adults.

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