We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.īeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. * This indication was approved under accelerated approval based on overall response rate. Currently, more than 40 additional regulatory submissions are in review around the world. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, China, the EU and Great Britain, Canada, Australia and additional international markets. 2021)*.īRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. 2021) and for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen ( Sept. 2019)* for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) ( Aug. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.īRUKINSA has previously been approved for three indications in the United States: for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy ( Nov. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With Adium’s established commercial presence in Latin America, we hope patients with MCL, MZL, and WM will soon have access to this important treatment option,” commented Eduardo Molinari, Senior Director of New Market Development in Latin America at BeiGene.īRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. “We are proud of the progress BeiGene has made in Latin America over the past year, with this approval in three indications in Uruguay following recent launches in Brazil, Chile and Ecuador. Karina Cicinelli, Corporate Medical Director at Adium. Today, we have a new treatment option for patients with MCL, MZL and WM in Uruguay, providing hope for improved treatment outcomes,” said Dr. “Tolerability of treatments for B-cell malignancies is an important consideration with BTK inhibition, and BRUKINSA was designed with that in mind to maximize BTK occupancy and minimize off-target binding. BeiGene and Adium entered into an exclusive distribution agreement for Adium to commercialize BRUKINSA in Latin America. MONTEVIDEO, Uruguay & CAMBRIDGE, Mass & BEIJING-(BUSINESS WIRE)-īeiGene (NASDAQ: BGNE HKEX: 06160 SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the BTK inhibitor BRUKINSA (zanubrutinib) has been approved in Uruguay for the treatment of adult patients with previously treated mantle cell lymphoma (MCL), relapsed or refractory marginal zone lymphoma (MZL), and Waldenström’s macroglobulinemia (WM). Under an exclusive distribution agreement, Adium will commercialize BRUKINSA in Latin America BRUKINSA is now available in four countries in Latin America, following previous approvals in Brazil, Chile, and Ecuador
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