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June 14, 2016

FDA grants Breakthrough Therapy Designation for Shire’s SHP621 and SHP625

Biopharmaceutical company Shire has received the US Food and Drug Administration’s (FDA) breakthrough therapy designation for its two investigational drug candidates.

By Lopamudra Roy

Biopharmaceutical company Shire has received the US Food and Drug Administration’s (FDA) breakthrough therapy designation for its two investigational drug candidates.

The investigational drugs are indicated to treat rare gastrointestinal illnesses such as SHP621 (budesonide oral suspension or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type II (PFIC2).

Shire CEO Flemming Ornskov said: "Receiving breakthrough therapy designation on two pipeline products this past week reflects the potential of our strong and innovative pipeline of more than 60 programmes.

"Shire is committed to bringing innovation to the rare and specialty areas we focus on. We persevere to see compounds through the many stages of development through their challenges and successes, and always keep patients with unmet needs top of mind."

"Receiving breakthrough therapy designation on two pipeline products this past week reflects the potential of our strong and innovative pipeline of more than 60 programmes."

EoE is a chronic and rare disease that results from an increased number of eosinophils, a type of white blood cell that infiltrate the walls of the oesophagus.

A patient affected with EoE might suffer from inflammation of the oesophagus that leads to difficulty in swallowing (dysphagia).

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BOS is a topically active, oral viscous formulation of budesonide developed particularly to treat EoE.

PFIC is a group of autosomal-recessive liver disorders of childhood that disturb the bile formation and present with cholestasis, while PFIC2 is the most common type of PFIC.

The PFIC symptoms include severe itching of the skin (pruritus) and jaundice.

According to preclinical models, Maralixibat is a potent, selective inhibitor of the apical sodium-dependent bile acid transporter (ASBT).

These ASBT inhibitors are designed to block bile acid re-absorption in the ileum and increases faecal bile acid excretion.

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