Date: 2015-12-29
Type of information: Granting of the orphan status in the US
Product name: VL-2397 - ASP2397 - cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III)
Compound: cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III)
Therapeutic area: Infectious diseases - Rare diseases
Action mechanism: antifungal agent. In preclinical studies to date, VL-2397 has demonstrated both faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. VL-2397 was initially developed by Astellas Pharma. In March 2015, Astellas granted Vical an exclusive worldwide license to develop and commercialize VL-2397.
Company: Vical (USA - CA)
Disease: invasive aspergillosis
Latest news: * On December 29, 2015, the FDA has granted Vical orphan drug designation for its investigational antifungal product candidate, VL-2397 (Cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III)) for the treatment of invasive aspergillosis. VL-2397 is part of a potential new class of antifungal compounds for the treatment of systemic fungal infections. Systemic fungal infections are major causes of morbidity and mortality in immunocompromised patients, such as transplant recipients, in patients undergoing chemotherapy and in patients in intensive care units.
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: 2015-12-29
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
