Date: 2015-03-31
Type of information: Granting of the orphan status in the US
Product name: IVA337 - lanifibranor
Compound: lanifibranor 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid
Therapeutic area: Rare diseases
Action mechanism:
- PPAR modulator. This compound is a peroxisome proliferator activated receptors (PPAR) modulator.
Company: Inventiva (France)
Disease: systemic sclerosis
Latest news:
- • On March 31, 2015, the FDA has granted orphan drug designation for 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid for the treatment of systemic sclerosis.
- • On 7-9 October 2014, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid for treatment of systemic sclerosis.
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: 2015-03-31
Orphan status UE: 2014-11-19
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
- • On September 18, 2017, Inventiva announced that the
World Health Organization (WHO) has granted it the international non-proprietary name (INN) lanifibranor for IVA337, currently is in Phase IIb development for both systemic sclerosis and non-alcoholic steatohepatitis. Results from the systemic sclerosis clinical trial are expected in the second half of 2018, while those of the NASH trial are due for early 2019.
Is general: Yes
