ADVANZ PHARMA secures temporary suspension of the European Commission decision on the OCALIVA conditional marketing authorisation in Europe

ADVANZ PHARMA secures temporary suspension of the European Commission decision on the OCALIVA® conditional marketing authorisation in Europe

• The European Commission's decision to revoke the OCALIVA® conditional marketing authorisation has been suspended with immediate effect by Order of the President of the General Court of the European Union
• The conditional marketing authorisation for OCALIVA® remains valid in Europe until further notice from the General Court
• OCALIVA® remains fully available for new and existing patients across Europe
  
  

London, UK - 5 September 2024: ADVANZ PHARMA Holdco Limited (ADVANZ PHARMA or the Company), a UK headquartered pharmaceutical company, today announces that the General Court of the European Union (General Court) has temporarily suspended the European Commission (EC) decision to revoke the conditional marketing authorisation (CMA) for OCALIVA® (obeticholic acid) in Europe (EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway) for second-line treatment of patients with the rare liver disease Primary Biliary Cholangitis (PBC).

The grant of the temporary suspension means that the CMA for OCALIVA® will remain in place for new and existing patients until further notice from the General Court, maintaining access to OCALIVA® for PBC patients in Europe.

Steffen Wagner, CEO at ADVANZ PHARMA, commented: "We are committed to supporting patients and are pleased to have secured a temporary suspension of the EC decision. This enables immediate continuity of supply until the next decision by the General Court. We will continue our efforts to help ensure longer-term continuity of supply of OCALIVA® for all patients who need it. OCALIVA® - an FXR agonist - has a different mechanism of action from other treatments, making it an important option for patients with PBC, a condition where treatment options are already very limited."

Patients should consult their treating physician if they have any questions.

Further information is available from [e-mail].

About OCALIVA® and PBC
Primary biliary cholangitis (PBC) is a rare, serious and progressive autoimmune disease that damages the bile ducts in the liver. OCALIVA® is a film-coated tablet containing obeticholic acid (OCA), a selective and potent agonist of the farnesoid X receptor (FXR) which regulates bile acid, inflammatory, fibrotic and metabolic pathways and decreases intracellular hepatocyte concentrations of bile acids. OCALIVA® is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network. ADVANZ PHARMA's product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. For more information, please visit our Website or LinkedIn.

For media enquiries, please contact:
ADVANZ PHARMA
Courtney Baines
Email: [e-mail]

ICR Consilium
Email: [e-mail]

GL/OCA/NP/0062
Date of preparation: September 2024