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Products

Date: 2012-04-06

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

Product name: adenovirus-associated viral vector serotype 2 containing the human RPE65 gene

Compound: adenovirus-associated viral vector serotype 2 containing the human RPE65 gene

Therapeutic area: Rare diseases - Genetic diseases - Ophtalmological diseases

Action mechanism: gene therapy

Company: Alan Boyd Consultants Ltd (UK)

Disease: Leber’s congenital amaurosis

Latest news:

  • • On 7-8 February 2012 the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for adenovirus-associated viral vector serotype 2 containing the human RPE65 gene for treatment of Leber’s congenital amaurosis.

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: 2012-04-06

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes