European Commission Approves Cresemba for Pediatric Use
Basilea Pharmaceutica Ltd, a biopharmaceutical company in the commercial stage, has reached a significant milestone in treating severe infections in pediatric patients. The European Commission has officially approved the antifungal medication Cresemba (isavuconazole) for use in children. This important decision also triggers a CHF 10 million milestone payment from Basilea's licensing partner, Pfizer Inc.
Importance of the Approval
Dr. Marc Engelhardt, Chief Medical Officer at Basilea, expressed his satisfaction with this approval, emphasizing Cresemba's critical role in treating invasive aspergillosis and mucormycosis in children. These serious conditions primarily affect young patients with hematologic malignancies or immunodeficiency disorders, highlighting a significant unmet need for effective antifungal therapies. With this decision, access to Cresemba is now available for this vulnerable group of patients across Europe.
Clinical Trials Leading to Approval
The approval was supported by encouraging results from two clinical trials involving pediatric patients aged 1 to 17 years. These studies included a phase 2 open-label trial aimed at evaluating the safety and efficacy of Cresemba in treating invasive fungal infections. The results were compelling, showing that isavuconazole is both effective and safe for younger patients facing these serious health challenges.
Extension of Market Exclusivity
Alongside the approval for pediatric use, the European Commission has granted an additional two years of market exclusivity for Cresemba in the European Union, extending the exclusivity period to October 2027. This extension is vital for Basilea, as it helps the company maintain a competitive edge in the market while increasing access to their products for those in need.
About Cresemba (Isavuconazole)
Isavuconazole, known by its trade name Cresemba, is an intravenous and oral azole antifungal that effectively targets invasive aspergillosis and mucormycosis. Basilea has established multiple licensing and distribution agreements for Cresemba in over 115 countries, with regulatory approvals in the European Union, the U.S., and several other global markets, including the U.K., China, and Japan. Additionally, it has received orphan drug designations in various regions due to its essential role in treating rare and serious conditions.
Company Overview
Basilea Pharmaceutica Ltd was founded in 2000 and has since concentrated on developing innovative drugs aimed at severe bacterial and fungal infections. The company has successfully launched two primary hospital brands: Cresemba and Zevtera, the latter focusing on bacterial infections. Furthermore, Basilea continues to expand its portfolio with a variety of preclinical and clinical anti-infective assets, demonstrating its commitment to tackling critical healthcare challenges.
Contact Information
If you have any questions regarding this announcement or need additional information about the company, please reach out to:
Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
Basilea Pharmaceutica International Ltd
Hegenheimermattweg 167b
4123 Allschwil
Switzerland
Phone: +41 61 606 1102
Email: media_relations@basilea.com, investor_relations@basilea.com
Frequently Asked Questions
What is the significance of the European Commission's approval?
This approval indicates that Cresemba is now officially recognized for use in pediatric patients, broadening the treatment options available for children with invasive fungal infections.
How does Cresemba benefit pediatric patients?
Cresemba offers an effective antifungal treatment for children suffering from severe infections, such as invasive aspergillosis and mucormycosis.
What are the future developments for Cresemba?
The market exclusivity for Cresemba has been extended by two years, now lasting until October 2027, which will support Basilea's strategic position in the market.
What evidence supported Cresemba's pediatric approval?
The pediatric approval was based on two clinical studies that demonstrated the safety and efficacy of Cresemba for children aged 1 to 17 years.
Where can I find more information about Basilea?
For more information about Basilea and its products, you can visit their official website, which details their ongoing commitment to innovative healthcare solutions.
