ADVANZ PHARMA’s response to the reversal of the suspension of the European Commission decision on the OCALIVA® conditional marketing authorisation in Europe
- The conditional marketing authorisation for OCALIVA® across the EU and EEA has been revoked with immediate effect
- ADVANZ PHARMA is considering next steps, including options to enable continued access for patients
London, UK – 27/11/2024: ADVANZ PHARMA Holdco Limited (ADVANZ PHARMA or the Company), a UK headquartered pharmaceutical company, today announces that following the grant of a temporary suspension, as announced on 5th September 2024, the General Court of the European Union (General Court) has decided not to further extend the suspension of 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).
This means that the EC’s revocation decision is in force, resulting in the CMA for OCALIVA® being revoked in Europe (EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway) with immediate effect.
The General Court Order only assessed whether there were “serious” and “irreparable” or “irreversible” damages to ADVANZ PHARMA caused by the EC decision, and did not assess patient impact or the overall validity of the EC decision. The overall validity of the EC decision is subject to an ongoing annulment procedure at the General Court which has not yet been ruled upon, and is anticipated in 2025.
Steffen Wagner, CEO at ADVANZ PHARMA, commented: “We are very disappointed by the General Court’s decision. OCALIVA® is a much-needed treatment option for thousands of patients with PBC in Europe. As an FXR agonist, OCALIVA® has a different mechanism of action from other treatments and is backed by a wealth of positive real-world evidence, gathered from more than seven years of clinical use. Without OCALIVA®, patients could be at increased risk of disease progression, including serious liver harm, liver transplantation or death. ADVANZ PHARMA disagrees with the EC revocation decision and remains committed to supporting patients with PBC and is in discussion with relevant national agencies to enable continued access for patients who rely on this medicine.”
The European Medicines Agency has referenced the ability for ADVANZ PHARMA to continue – subject to local laws and regulations – to supply OCALIVA® in Europe on a compassionate access or named patient programme basis for existing patients. ADVANZ PHARMA is committed to supporting patients and will ensure supplies are available depending on national competent authority approved provisions.
Patients affected should consult their treating physician if they have any questions.
Further information is available from medicalinformation@advanzpharma.com.
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.
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ADVANZ PHARMA
Courtney Baines
Email: courtney.baines@advanzpharma.com
