ADVANZ PHARMA Achieves Stopgap in OCALIVA® Marketing Decision
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ADVANZ PHARMA Gains Temporary Suspension on OCALIVA® Decision
ADVANZ PHARMA has successfully secured a temporary suspension of the European Commission's decision to revoke the conditional marketing authorization for OCALIVA®. This significant ruling was delivered by the President of the General Court of the European Union, allowing the conditional marketing authorization for OCALIVA® to remain valid throughout Europe.
Importance of the Suspension
This suspension ensures that OCALIVA® will continue to be accessible for both new and existing patients across the European Union. Patients suffering from Primary Biliary Cholangitis (PBC), a rare liver disease, can rely on OCALIVA® (obeticholic acid) as a viable treatment option during this period.
CEO Statement on Patient Commitment
Steffen Wagner, CEO of ADVANZ PHARMA, expressed confidence in the company’s commitment to supporting patients. "We are thrilled to have achieved this temporary suspension, which enables immediate continuity of supply until a further decision is made by the General Court. We understand the importance of OCALIVA® and the unique role it plays as a treatment option for patients with limited alternatives,” he stated.
Understanding OCALIVA® and Its Role in Treating PBC
OCALIVA® is a film-coated tablet and a potent agonist of the farnesoid X receptor (FXR). It works by regulating various pathways, including those linked to bile acids and inflammation. The conditional marketing authorization allows the use of OCALIVA® either in conjunction with ursodeoxycholic acid or as a standalone treatment for adults who are unable to tolerate the latter.
About ADVANZ PHARMA’s Global Vision
ADVANZ PHARMA is dedicated to enhancing patient care by offering specialty medicines in numerous markets worldwide, with commercial sales extending to over 90 countries. The company maintains a significant presence in Europe, the U.S., Canada, and Australia, along with a specialized Centre of Excellence in Mumbai, India. Their portfolio includes a variety of innovative treatments across different therapeutic areas, such as hepatology, oncology, and rare diseases.
Contact Information
For further inquiries regarding OCALIVA® or other ADVANZ PHARMA products, patients and healthcare providers can reach out to the company’s medical information team at medicalinformation@advanzpharma.com. For media inquiries, Courtney Baines can be contacted via email at courtney.baines@advanzpharma.com.
Frequently Asked Questions
What does the suspension of the European Commission's decision mean for patients?
The suspension ensures that OCALIVA® remains available to patients, providing continuity of treatment during this period.
What is OCALIVA® used for?
OCALIVA® is used for the treatment of Primary Biliary Cholangitis (PBC) in adult patients, particularly those who do not respond well to standard treatments.
Who can benefit from OCALIVA® treatment?
Adults with PBC who have inadequate responses to ursodeoxycholic acid or cannot tolerate it are eligible for OCALIVA® treatment.
How does OCALIVA® work?
OCALIVA® acts as an FXR agonist, modulating important biological pathways that help manage bile acid levels and reduce inflammation in the liver.
Where can I get more information about ADVANZ PHARMA?
For more details on ADVANZ PHARMA and its products, you can visit their official website or contact their medical information team directly.
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