Aeterna Zentaris Receives European Marketing Clearance for Macimorelin

Aeterna Zentaris (NASDAQ:AEZS;TSX:AEZS) announced that the European Medicines Agency (EMA) has granted marketing authorization for macimorelin, an orally available ghrelin agonist, for diagnosis of adult growth hormone deficiency (AGHD).

As quoted in the press release:

“Clinical studies have demonstrated that macimorelin is safer and much simpler to administer than the current methods of testing for insulin-induced hypoglycemia, and is well-tolerated by patients and reliable in diagnosing the condition,” said Dr. Christian Strasburger, the Head of Clinical Endocrinology at Charité Unversitaetsmedizin Berlin and the principal investigator for macimorelin. “Both patients and healthcare-providers will undoubtedly welcome the general availability of macimorelin and I believe that macimorelin will become the generally accepted new reference procedure for diagnosing adult growth hormone deficiency.”

AGHD may occur in an adult subject who has a history of childhood onset growth hormone deficiency (GHD) or may occur during adulthood as an acquired condition. Considering a population of 510 million for the European Community, research based on incidence prevalence suggests that at least 35,000 adults could be afflicted with GHD.

“The EMA approval of macimorelin further validates the value of the product and will assist in our efforts to create value for our shareholders from macimorelin,” said Michael V. Ward, Chief Executive Officer, Aeterna Zentaris.

Click here to read the full press release.