ADVANZ PHARMA Secures Temporary Suspension of OCALIVA® Decision
ADVANZ PHARMA has successfully obtained a temporary suspension of the European Commission's decision to revoke the conditional marketing authorization for OCALIVA®. This important ruling was issued by the President of the General Court of the European Union, allowing the conditional marketing authorization for OCALIVA® to remain effective throughout Europe.
Significance of the Suspension
This suspension guarantees that OCALIVA® will remain accessible to both new and existing patients within the European Union. Those suffering from Primary Biliary Cholangitis (PBC), a rare liver condition, can continue to rely on OCALIVA® (obeticholic acid) as a viable treatment option during this time.
CEO's Commitment to Patients
Steffen Wagner, the CEO of ADVANZ PHARMA, expressed his confidence in the company’s dedication to supporting patients. "We are delighted to have secured this temporary suspension, which allows for the immediate continuity of supply until a further decision is reached by the General Court. We recognize the significance of OCALIVA® and the unique role it serves as a treatment option for patients with limited alternatives,” he remarked.
Understanding OCALIVA® and Its Role in PBC Treatment
OCALIVA® is a film-coated tablet that acts as a potent agonist of the farnesoid X receptor (FXR). It functions by regulating several pathways, including those related to bile acids and inflammation. The conditional marketing authorization permits the use of OCALIVA® either alongside ursodeoxycholic acid or as a standalone treatment for adults who are unable to tolerate the latter.
ADVANZ PHARMA’s Global Vision
ADVANZ PHARMA is committed to improving patient care by providing specialty medicines in various markets around the world, with commercial sales spanning over 90 countries. The company has a strong presence in Europe, the U.S., Canada, and Australia, along with a specialized Centre of Excellence located in Mumbai, India. Their portfolio features a range of innovative treatments across multiple therapeutic areas, including hepatology, oncology, and rare diseases.
Contact Information
For additional inquiries about OCALIVA® or other ADVANZ PHARMA products, patients and healthcare providers can contact the company’s medical information team at medicalinformation@advanzpharma.com. For media inquiries, Courtney Baines can be reached 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.
