Products

Date: 2014-12-16

Type of information: Granting of the orphan status in the EU

Product name: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine

Compound: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine

Therapeutic area: Rare diseases

Action mechanism: peptide

Company: Mimetech (Italy)

Disease: neurotrophic keratitis

Latest news:

• • On November 11-13, 2014, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine for treatment of neurotrophic keratitis.

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:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE: 2014-12-16

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes