SOMATROPIN MARKET ANALYSIS

Market News

Global Somatropin Market- Key Developments

On April 28 2023, Novo Nordisk A/S, a global healthcare company, announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone. With this new indication, Sogroya becomes the first and only once-weekly growth hormone (GH) treatment for both children and adults. The FDA approval of the new indication for children with GHD is based on data from the phase 3 REAL4 study.

In November 2020, Aeterna Zentaris, a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, announced that it has entered into an amendment of its existing License Agreement with Novo Nordisk A/S, a global healthcare company related to the development and commercialization of macimorelin, which is used for the diagnosis of adult growth hormone deficiency (AGHD).

In January 2020, Ferring B.V., a biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has approved ZOMACTON (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.

In April 2021, Merck KGaA, a multinational science and technology company, has signed up with PRA Health Sciences to wed its human growth hormone (HGH) treatment system with the CRO’s remote patient monitoring platform. Under the terms of this new agreement, the financial details of which were not made public, PRA's platform will support Merck's HGH treatment system, including grow link, an app for patients who are prescribed the pharmaceutical company's HGH treatment, known as Saizen (somatropin), and easy pod Connect, a platform for endocrinology professionals to monitor patients' adherence, review injection histories, and share information about patients' progression.

In February 2022, Pfizer Inc., a multinational pharmaceutical and biotechnology corporation, and OPKO Health, Inc., a medical test and medication company focused on diagnostics and pharmaceuticals, announced that the European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone NGENLA (somatrogon), a once-weekly injection to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. NGENLA provides pediatric patients, their caregivers and healthcare providers with a new treatment option for growth hormone deficiency (GHD) that reduces the frequency of required injections from once daily to once weekly.