Pharmbio announced on Thursday that it has signed an exclusive national supply contract for Macrilen (component: macrimorelin), a new drug for diagnosing adult growth hormone deficiency (AGHD), manufactured by the Canadian company Aeterna Zentaris.
AGHD is a disease that has various clinical patterns, such as short stature, decreased growth rate, cardiovascular disorders, arteriosclerosis, and insulin resistance in childhood, due to lack of secretion of growth hormones in the human body.
Current diagnosis of growth hormone deficiency requires multiple blood draws over a long period, and diagnosis of existing growth hormone shows patterns of wave secretion through stimulation testing. As a result, hospitalization is limited due to abnormal response monitoring and frequent blood sampling.
However, Macrilen does not require hospitalization as it only requires four blood samples for approximately one and a half hours after oral use.
Macrilene has been shown to be effective and safe. Additionally, the American Association of Clinical Endocrinology (AACE) guidelines for growth hormone deficiency have recommended it as a reproducible, highly accurate, and easy to perform test compared to conventional insulin loading tests and with arginine, according to Pharmbio Korea.
Macrilen has obtained approvals from the United States Food and Drug Administration and the European Medicines Agency (EMA). The Ministry of Food and Drug Safety (MFDS) designated it as a rare drug on June 10.
In North America, it is sold through a license agreement with Novo Nordisk. A joint clinical trial for the expansion of the pediatric indication will soon be completed. Subsequently, the co-developers will appeal to the FDA and the EMA to extend its indications.
“We are excited to introduce Macrilen to Korea, confident of its safety and convenience.” Pharmbio Korea President Nam Bong-gil said, “Macrilen is expected to leave a big footprint on HDGA diagnostic options, which have been underdeveloped so far.