Products

Date: 2018-02-13

Type of information: Granting of the orphan status in the US

Product name: inter-Alpha-Inhibitor-Proteins (IaIp)

Compound: inter-Alpha-Inhibitor-Proteins (IaIp)

Therapeutic area: Rare diseases - Inflammatory diseases

Action mechanism:

• enzyme inhibitor/serine proteases inhibitor. Inter-alpha inhibitor proteins (IaIp) are serine proteases inhibitors that modulate endogenous protease activity. Severe sepsis results in reduced I?Ip with the loss of protease inhibitory activity.
• IaIp are endogenous proteins that control excessive inflammatory responses to toxins, infectious organisms, and tissue and organ damage. An inverse correlation between IaIp levels in plasma and disease severity / mortality has been demonstrated in humans with sepsis.  In a gold-standard animal model proven to emulate NEC in humans, the supplementation of IaIp significantly increased the survival rate.

Company: Prometic Life Science (Canada)

Disease: necrotizing enterocolitis

Latest news:

• • On February 13, 2018, the FDA has granted orphan drug designation status to Inter-Alpha-Inhibitor-Proteins (“IaIp”) for the treatment of necrotizing enterocolitis.

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: 2018-02-13

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes