Date: 2016-10-14
Type of information: Granting of the orphan status in the EU
Product name: F901318
Compound: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]- phenyl}-2-oxo-acetamide
Therapeutic area: Infectious diseases
Action mechanism:
Company: F2G (UK)
Disease: invasive aspergillosis
Latest news: * On 6-8 September, 2016, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide for treatment of invasive aspergillosis. * On November 30, 2015, F2G announced that its novel systemic antifungal product F901318 has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways pilot programme. Initiated in March 2014, the Adaptive Pathways (formerly Adaptive Licensing) pilot programme forms part of the EMA’s strategy to provide improved access to new therapies treating serious conditions where there is a high unmet medical need. This concept foresees either an initial approval in a well-defined patient subgroup with a high medical need and subsequent widening of the indication to a larger patient population, or an early regulatory approval (e.g. conditional approval) which is prospectively planned, and where uncertainty is reduced through the collection of post-approval data on the medicine’s use in patients. This approach builds on regulatory processes already in place within the existing European Union legal framework. F2G announced that the company will seek initial approval for F901318, a novel IV and oral, systemic antifungal targeted at invasive aspergillosis on the basis of a Phase IIb randomised controlled clinical trial.
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: 2016-10-14
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
