Recordati receives orphan drug designation for its investigational treatment for neurotrophic keratitis

21 December 2018 - Recordati announced that the FDA has granted Orphan Drug Designation to Recordati Rare Disease’s investigational product REC 0559 for the treatment of neurotrophic keratitis

Recordati announced that the FDA has granted Orphan Drug Designation to Recordati Rare Disease’s investigational product REC 0559 for the treatment of neurotrophic keratitis.

REC 0559 is a low molecular weight non-peptidic human nerve growth factor (NGF) mimetic currently under global development by Recordati. REC 0559 was licensed in 2017 from MimeTech, an Italian based company focused on the development of pharmaceutical applications for synthetic neurotrophin mimetics.

The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design and an exemption from FDA user fees.

For more information: http://www.recordati.com/resources/Pubblicazione/___1c6f901a5037416d82625ca16b7314d2_/fda-orphan-drug-designation-for-nk.pdf

Where to find us

20149 Milan
Via Giovanni da Procida, 11
Show map 
Tel. +39 02.34565.1
Fax. +39 02.34565.310
Segreteria Assobiotec
Tel. 02 34565.256/341
assobiotec@federchimica.it