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December 1, 2017

FDA grants orphan drug status to Shire’s UC treatment SHP647

The US Food and Drug Administration (FDA) has granted orphan drug designation to Shire’s investigational mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antibody, SHP647, for the treatment of paediatric patients with moderately to severely active ulcerative colitis (UC).

The US Food and Drug Administration (FDA) has granted orphan drug designation to Shire’s investigational mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antibody, SHP647, for the treatment of paediatric patients with moderately to severely active ulcerative colitis (UC).

MAdCAM-1 plays a significant role in leukocyte trafficking in the person’s gastrointestinal (GI) tract and appears to allow excessive lymphocyte infiltration under conditions of chronic GI inflammation.

Formerly known as PF-00547659, Shire’s SHP647 is a fully human IgG2 monoclonal antibody that directly targets the MAdCAM-1, and inhibits α4β7 integrin binding to human MAdCAM-1 with high affinity and selectivity.

The biopharmaceutical company is currently evaluating the therapy in Phase III studies for the treatment of moderately to severely active UC in adult patients.

“We’re pleased to receive orphan drug designation for SHP647, and we’re excited about our continued work to develop this compound.”

Shire’s plan to conduct paediatric study on SHP647 is currently under discussion with health authorities.

Shire Therapeutic Area Development GI, Endocrine and Metabolism lead Dr Debra Silberg said: “We’re pleased to receive orphan drug designation for SHP647, and we’re excited about our continued work to develop this compound.

“If approved, SHP647 holds the potential to help treat patients with UC. Shire’s study plans for SHP647 in the paediatric population align well with our commitment to address unmet patient need.”

In October this year, the company received orphan drug designation for its gene therapy candidate SHP654 (BAX 888) from the US FDA.

SHP654 is an investigational factor VIII (FVIII) gene therapy for the treatment of patients with haemophilia A.

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