Products

Date: 2017-12-20

Type of information: Granting of a Market Authorisation in the US

Product name: Macrilen™

Compound: macimorelin

Therapeutic area: Endocrine diseases - Hormonal diseases

Action mechanism:

• hormone-release stimulating peptide. Macimorelin is  growth hormone secretagogue receptor agonist. It stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Stimulated growth hormone levels are measured in blood samples over ninety minutes after oral administration of macimorelin for the assessment of growth hormone deficiency.

Company: Aeterna Zentaris (Canada)

Disease: diagnosis of patients with adult growth hormone deficiency (AGHD)

Latest news:

• • On December 20, 2017, the FDA has granted marketing approval for Macrilen™ (macimorelin), an orally available ghrelin agonist, to be used in the diagnosis of patients with adult growth hormone deficiency (AGHD). Prior to the approval of Macrilen™, the gold standard for evaluation of AGHD was the insulin tolerance test. Aeterna Zentaris intends to make available commercially in the United States during the first quarter of 2018.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2017-12-20

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA: 2007-05-14

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes