FDA News

FDA approves oral ghrelin agonist for adult GH deficiency diagnosis

The FDA has approved the oral ghrelin agonist macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency, according to a press release from Aeterna Zentaris.

Macimorelin (Macrilen) will be used to stimulate the secretion of GH from the pituitary gland into the circulatory system.

“Aeterna Zentaris is proud of our commitment to patients with suspected [adult growth hormone deficiency] and to the endocrinology community who we are confident will welcome an easier safe and effective oral diagnostic tool,” Michael V. Ward, CEO of Aeterna Zentaris, said in the release. “In the absence of an FDA-approved diagnostic test for [adult growth hormone deficiency], Macrilen fills an important gap and addresses a medical need for a convenient test that will better serve patients and health providers.”

Stimulated GH levels will be measured over 90 minutes after administration of macimorelin through four blood samples. The historical gold standard of evaluation of adult GH deficiency was the insulin tolerance test, which is often inconvenient for patients and medical practitioners and may be contraindicated in patients with coronary heart disease or seizure disorder, according to the release.

“Clinical studies have demonstrated that growth hormone stimulation testing for [adult growth hormone deficiency] with oral Macrilen (macimorelin) is reliable, well-tolerated, reproducible, safe and a much simpler test to conduct than currently available options,” Kevin Yuen, MD, clinical investigator and endocrinologist at Barrow Neurological Institute and medical director of the Barrow Neuroendocrinology Clinic in Pheonix, said in the release. “The availability of Macrelin (macimorelin) will greatly relieve the burden of endocrinologists in reliably and accurately diagnosing [adult growth hormone deficiency].”

 

The FDA has approved the oral ghrelin agonist macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency, according to a press release from Aeterna Zentaris.

Macimorelin (Macrilen) will be used to stimulate the secretion of GH from the pituitary gland into the circulatory system.

“Aeterna Zentaris is proud of our commitment to patients with suspected [adult growth hormone deficiency] and to the endocrinology community who we are confident will welcome an easier safe and effective oral diagnostic tool,” Michael V. Ward, CEO of Aeterna Zentaris, said in the release. “In the absence of an FDA-approved diagnostic test for [adult growth hormone deficiency], Macrilen fills an important gap and addresses a medical need for a convenient test that will better serve patients and health providers.”

Stimulated GH levels will be measured over 90 minutes after administration of macimorelin through four blood samples. The historical gold standard of evaluation of adult GH deficiency was the insulin tolerance test, which is often inconvenient for patients and medical practitioners and may be contraindicated in patients with coronary heart disease or seizure disorder, according to the release.

“Clinical studies have demonstrated that growth hormone stimulation testing for [adult growth hormone deficiency] with oral Macrilen (macimorelin) is reliable, well-tolerated, reproducible, safe and a much simpler test to conduct than currently available options,” Kevin Yuen, MD, clinical investigator and endocrinologist at Barrow Neurological Institute and medical director of the Barrow Neuroendocrinology Clinic in Pheonix, said in the release. “The availability of Macrelin (macimorelin) will greatly relieve the burden of endocrinologists in reliably and accurately diagnosing [adult growth hormone deficiency].”