Products

Date: 2017-06-15

Type of information: Positive opinion for the granting of the orphan status in the EU

Product name: Bacillus subtilis oxalate decarboxylase

Compound: Bacillus subtilis oxalate decarboxylase

Therapeutic area: Rare diseases - Kidney diseases - Renal diseases

Action mechanism: enzyme. This orally-administered, recombinant oxalate-degrading enzyme targets oxalate in the gastrointestinal tract in an effort to reduce the burden of both dietary and endogenously produced oxalate.

Company: Allena Pharmaceuticals (USA - MA)

Disease: primary hyperoxaluria

Latest news:

• On June 15, 2017, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for Bacillus subtilis oxalate decarboxylase for treatment of primary hyperoxaluria.

 

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:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes