Date: 2010-10-01
Type of information: Granting of the orphan status in the EU
Product name: 16-base single-stranded peptide nucleic acid oligonucleotide linked to a 7-amino acid peptide
Compound: 16-base single-stranded peptide nucleic acid oligonucleotide linked to a 7-amino acid peptide
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: antisens oligoucleotide. 16-Base single-stranded peptide nucleic acid oligonucleotide linked to a 7-amino acid peptide has been designed to block the gene coding for MYCN protein. This protein is involved in the growth, progression and spread of medulloblastoma cells.
Company: Biogenera (Italy)
Disease: medulloblastoma
Latest news: * On October 1, 2010, orphan designation was granted by the European Commission for 16-base single-stranded peptide nucleic acid oligonucleotide linked to a 7- amino acid peptide for the treatment of medulloblastoma.
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: 2010-10-01
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
