Nanolek LLC announces the inclusion of the innovative oncohematological drug Brukinsa® (zanubrutinib) into the List of Vital and Essential Drugs (VED). The respective order was signed on January 15 by Mikhail Mishustin, Chairman of the Government of the Russian Federation. The inclusion of Brukinsa® into the List of VED will significantly increase the availability of the innovative drug therapy for patients with oncohematological diseases.
The drug Brukinsa® (zanubrutinib) is aimed at treating patients with chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma. Chronic lymphocytic leukemia is one of the most common B-cell tumors. The annual incidence is 2.95 cases per 100 thousand patients. Mantle cell lymphoma is a rare, but extremely aggressive oncohematological disease, occurring with a frequency of 0.5-0.7 cases per 100 thousand people under 65 years of age, and 3.9 cases in the older age group. In Russia, such a diagnosis is detected annually in approximately 2,500 patients. Most often, the pathology is detected in men after 60 years of age, and it is diagnosed in most cases at an advanced stage.
Brukinsa® is part of the manufacturing portfolio of Nanolek LLC. In 2021, as part of a strategic agreement concluded with the global oncology company BeiGene, Nanolek LLC received the exclusive rights to distribute, promote, pharmacovigilance, as well as secondary packaging and release quality control of Brukinsa® in the Russian Federation and the countries of the Eurasian Economic Union.
Inclusion of the drug into the List of Vital and Essential Drugs opens up broad opportunities to provide patients with chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma with innovative drug therapy throughout Russia. The effectiveness of the drug has been confirmed in clinical trials.
"The most important condition for the effective fight against oncohematological diseases is to ensure the necessary level of drug provision, since such diseases are treated with therapeutic methods. The innovative therapy plays a decisive role in the treatment of a number of oncohematological nosologies. Therefore, inclusion of Brukinsa® into the List of Vital and Essential Drugs is a significant event for patients with chronic lymphocytic leukemia and mantle cell lymphoma. The company Nanolek LLC as a manufacturer at the final stage of this drug confirms its readiness to ensure its availability in the volumes necessary for the healthcare system," says Elena Stukun, Deputy General Director for Commercial Activities of Nanolek LLC.
The List of Vital and Essential Drugs includes more than 800 international non-proprietary names and more than 5,000 trade names of medicines. The price of such medicines is regulated by the state. The List of Vital and Essential Drugs is compiled by a special Commission of the Ministry of Health of the Russian Federation, and then it is approved by the Government. Besides Brukinsa®, in 2025 the List will include 17 more INNs for the treatment of life-threatening diseases (Government Order No. 10-r of 15.01.2025 on amendments to Order No. 2406-r of 12.10.2019).
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