antiviralresearch

FDA fast tracks Shire’s SHP626 nonalcoholic steatohepatitis drug

pharmafile | July 29, 2016 | News story | Research and Development FDA, SHP626, Shire, liver fibrosis, nash, volixibat, volxibat 

The Food and Drug Administration (FDA) has granted Fast Track designation to Shire’s SHP626 (volixibat) treatment for patients suffering from non-alcoholic steatohepatitis (NASH) with liver fibrosis.

The FDA’s Fast Track process is designed to facilitate the development and review of drugs to treat conditions which inflict serious adverse effects or for which there is an unmet medical need, though it does not guarantee approval. The body’s decision was based on SHP626’s supportive preclinical and Phase II studies.

NASH is a type of nonalcoholic fatty liver disease (NAFLD) causing inflammation and the accumulation of fat in the liver, for which there are currently no approved drugs. SHP626 is being developed as a once daily orally-administered inhibitor of the apical sodium dependent bile acid transporter (ASBT), a protein which is primarily responsible for recycling bile acids from the intestine to the liver.

Advertisement

“Shire’s development plan for SHP626 is designed to address the unmet need in the treatment of adult patients who have NASH with liver fibrosis,” commented Philip J. Vickers, head of R&D at Shire. “This Fast Track designation is further recognition of the critical need to develop new, effective therapeutic options for patients with this serious condition.”

Matt Fellows

Related Content

MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance

Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …

Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation

Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …

Johnson & Johnson submits robotic surgical system for De Novo classification

Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …

The Gateway to Local Adoption Series

Latest content