Obeticholic acid approved by NICE for the treatment of patients with PBC
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Obeticholic acid approved by NICE for the treatment of patients with PBC

Obeticholic acid approved by NICE for the treatment of patients with PBC

First new medication for Primary Biliary Cholangitis in nearly 20 years

 

The PBC Foundation today welcomes the news that the first new treatment for 20 years has become available for patients with PBC. Affecting 22,000 patients in the UK, 90% of whom are women. Estimated that 1 in 1000 women over the age of forty have PBC, it is the single biggest cause of liver transplants among women in the UK.

The National Institute for Health and Care Excellence (NICE) approved the brand new treatment Obeticholic Acid (OCA) for patients living with PBC, for whom the first-line medication hasn’t worked.  Historically, this cohort of patients would have mainly progressed to transplant or death.  By slowing down the rate of progression of liver damage, this medication has the potential to save many lives.  In an unprecedented move, NICE approved this new medication on its first attempt and we very much hope that this sets a new precedent for medications in the rare disease field.

Professor David Jones, Director of the UK-PBC group which undertook much of the work that led to the approval of Ocaliva said "this is a really important day for PBC patients and a great example of patients, scientists, doctors, industry and regulators working together to make difference. We are also very grateful to the Medical Research Council and National Institute for Health Research for their support of PBC research. What is so important to say is that Ocaliva is manufactured in the UK and exported around the world so the UK is taking a lead in work that truly benefits people around the world. A good day"

“It is exciting news for PBC patients, and their families, that this new treatment option will now be available in England, Wales and Northern Ireland,” said Collette Thain MBE, CEO of the PBC Foundation. “When I was first diagnosed with PBC, there was only one treatment option available and if that treatment failed, then there was no second option.  Thankfully, since then, so much has changed for people living with PBC.  After twenty years of advocacy on behalf of the PBC community, we now have a new treatment option, a growing awareness of the disease amongst the general public, world-leading expertise amongst UK clinicians and the acceleration of PBC research in the UK and around the globe.”

It is an unprecedented move for NICE to have approved this new medication on its first attempt and we very much hope that this sets a new precedent for medications in the rare disease field. We are delighted that NICE are being supportive, innovative and progressive in their approach to bring thousands of patients hope, health and a longer life.

 

ENDS

 

Download: Press release with Notes for Editor