Shire’s NASH candidate gains FDA fast track as it races into PhII

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The FDA will speed up its review of Shire’s ($SHPG) experimental midstage fatty liver disease drug volixibat as the battle to be first to market in this emerging disease area heats up.

The Irish biopharma has been given the track designation from the U.S. regulator for SHP626 (also known as volixibat) for nonalcoholic steatohepatitis (NASH) with liver fibrosis. This condition, which is estimated to affect millions of Americans, is directly related to the rise of obesity and type II diabetes, and can lead to liver cirrhosis, cancer and death.

“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,” said Philip Vickers, head of R&D, Shire.


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“This fast track designation is further recognition of the critical need to develop new, effective therapeutic options for patients with this serious condition.”

There are currently no approved meds in this area, but analysts believe--as with the hep C drugs from Gilead ($GILD)--a highly efficacious treatment that could cure patients of the condition could be a major blockbuster contender, with predictions being as high as $10 billion at peak per med.

Shire is racing Gilead, Intercept Pharmaceuticals ($ICPT), Genfit and others in what could eventually be a $40 billion market, although most of its rivals are further up the path than the biopharma in development terms.

Intercept appears to be the nearest to market after gaining in May an FDA approval for Ocaliva in a separate liver disease license known as primary biliary cirrhosis (PBC)--in what is being seen as a precursor to a NASH license. The biotech has however come up against problems as last year it flubbed a Phase II NASH test, but it has shown promise in other trials.

A year ago, Intercept began enrollment in a new global study for its NASH candidate designed to show if it can reduce liver scarring and prevent death and end-stage liver disease.

Final data won't be ready until 2021, but Intercept has scheduled an interim analysis in 2017 that will evaluate how well its drug is doing at resolving NASH and reducing scars in about 1,400 patients. It has said it plans to submit those results to the FDA for a shot at early approval.

Meanwhile Genfit, likely a second-place contender, has told FierceBiotech that it expects its drug to be approved by the FDA in 2019. Shire and Gilead are a little further down the ladder.  

Shire’s candidate is a once daily pill that works as an inhibitor of the apical sodium dependent bile acid transporter--a protein which is primarily responsible for recycling bile acids from the intestine to the liver.

It’s been in Phase I but is now set to move into midstage, placebo-controlled studies. The drug was originally licensed from Lumena Pharmaceuticals.

- check out the release

Related Articles:
Intercept Pharma gets accelerated FDA OK for liver drug Ocaliva
Genfit moves liver disease pill into mid-stage, hints at upcoming IPO
Gilead bags early-stage NASH drug in $1.2B Nimbus deal


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