ADVANZ PHARMA's Stance on OCALIVA® Marketing Authorization Revocation
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ADVANZ PHARMA's Response to Revocation of OCALIVA®
ADVANZ PHARMA Holdco Limited, a renowned pharmaceutical entity, has issued a significant response to the recent revocation of the conditional marketing authorization (CMA) for OCALIVA® in Europe by the European Commission. OCALIVA® is recognized as the only approved farnesoid X receptor (FXR) agonist for treating patients with the rare disease Primary Biliary Cholangitis (PBC).
Impact of the European Commission's Decision
As the sole second-line treatment option previously available, the EC's decision puts numerous patients facing PBC at a heightened risk of disease progression. ADVANZ PHARMA is evaluating all possible avenues to ensure these patients retain access to OCALIVA®.
According to Steffen Wagner, the CEO, this decision undermines years of treatment progress for thousands of individuals who have responded positively to OCALIVA®. The company is dedicated to collaborating with all relevant authorities in the EU to maintain the availability of this crucial treatment.
Importance of OCALIVA® in Treating PBC
OCALIVA® has been available since its conditional approval in December 2016, standing as the only effective second-line option for PBC patients in Europe. This medicine provides a unique mechanism of action that is critical given the scarcity of treatment choices available for this serious autoimmune disease.
Evidence Supporting OCALIVA®
ADVANZ PHARMA argues that the CHMP's recommendation to revoke the CMA did not thoroughly consider extensive real-world evidence supporting OCALIVA®'s efficacy and safety. This evidence spans over seven years and includes treatment of more than 47,000 patient-years, yet the recommendation primarily leaned on a singular randomized placebo-controlled trial, which had notable limitations.
Support from Health Communities
The removal of OCALIVA® has raised concerns among patients, healthcare experts, and scientific societies. Many advocate that OCALIVA® remains a vital second-line treatment in existing clinical guidelines, underscoring its importance in managing this life-threatening disease. The EMA has also indicated that ADVANZ PHARMA could, under local regulations, continue supplying OCALIVA® on a compassionate basis or through named patient programs.
Commitment to Patient Care
ADVANZ PHARMA is firmly dedicated to patient support and ensuring that OCALIVA® is available as per national regulations. They urge patients with concerns to consult their healthcare providers promptly.
About OCALIVA® and PBC
Primary Biliary Cholangitis (PBC) is recognized as a severe progressive autoimmune disorder that inflicts damage on the liver's bile ducts. OCALIVA® is presented as a film-coated tablet containing obeticholic acid, an effective FXR agonist, that is crucial in regulating several physiological pathways in the liver.
ADVANZ PHARMA Overview
As a global pharmaceutical entity, ADVANZ PHARMA aims to enhance patients' lives by delivering specialty and rare disease medicines. The company operates in over 90 countries, with a firm commitment to developing and commercializing innovative medicines across various therapeutic fields.
Frequently Asked Questions
What is the significance of OCALIVA® for PBC patients?
OCALIVA® is the only approved second-line treatment for PBC, critical for patients whose condition has not responded adequately to other therapies.
What steps is ADVANZ PHARMA taking in response to the withdrawal?
ADVANZ PHARMA is exploring all available options to ensure continued patient access to OCALIVA® and is committed to working with regulatory authorities.
How has the medical community reacted to the decision?
There is widespread concern among doctors and scientific societies regarding the impact of the EC’s decision, advocating for the continued availability of OCALIVA®.
What evidence supports the safety and efficacy of OCALIVA®?
ADVANZ PHARMA emphasizes that over seven years of real-world evidence supports the medicine's use, despite the EC's reliance on limited trial data.
Who should patients contact for more information?
Patients should consult their treating physician for any concerns regarding their treatment options and access to OCALIVA®.
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