Servier: Oncaspar (a drug for the therapy of acute lymphoblastic leukemia)

Main article: Leukemia (leukemia, blood cancer)

2022: Registration according to EAEU rules

On February 9, 2022, the pharmaceutical company Servier announced the registration of the original drug pegaspargase (Oncaspar) according to the rules of the EAEU. The antitumor cytostatic agent is used in combination with other antitumor drugs for the therapy of acute lymphoblastic leukemia (ALL) in adults and children (from birth to 18 years old). The registration certificate allows the medical use of the drug from February 4, 2022.

Pegaspargase is a pegylated form of the enzyme asparaginase, which splits the amino acid asparagine. Healthy cells are able to synthesize asparagine, while tumor cells of ALL patients lose this ability and depend on asparagine entry from. blood After administration of pegaspargase, the level of blood asparagine decreases, tumor cells do not receive it in sufficient amount and die, the vital activity of healthy cells suffers to a minimum extent. Since 2008, pegaspargase has been a key component of the main Russian protocol "-" MoscowBerlin for the treatment of acute lymphoblastic leukemia - the most common oncological disease in children and adolescents. Pegaspargase is included in the Approximate list of essential medicines. of the World Health Organization

Registration of the original pahaspargase in the form of lyophilisate for the preparation of a solution for intramuscular administration and infusions was the first ever registration of the drug according to the decentralized procedure of the EAEU. The reference country, the Russian Federation, conducted an examination, registered and approved Onkaspar for medical use. Registration certificates in other EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan) are expected in the near future.

Our main goal has been achieved - in Russia and other countries of the EAEU, the availability of therapy with the original drug pahaspargase has been ensured. In March-April 2020, we completed actions to submit dossier documents within 14 working days to all EAEU countries. All necessary measures were taken to get the approval of the Russian Ministry of Health and subsequent recognition by other countries as soon as possible, "said Natalya Chukreeva, D. Farm. N., Director of Pharmaceutical Activities for the EAEU countries of Servier.

It is expected that in Russia the first series of the drug Onkaspar will enter civil circulation in the first half of 2023.

Registration of the drug pegaspargase is a very expected and important event: both for patients and the medical community, and will undoubtedly be an important step in increasing the availability of therapeutic solutions for patients with acute lymphoblastic leukemia in the countries of the Eurasian Economic Union, "commented Yana Rostovtseva, Managing Director of Servier for Russia.

The original pegaspargase is a drug that has been used since 2008 as part of the official Moscow-Berlin protocol for the treatment of acute lymphoblastic leukemia, which regulates the provision of care in the vast majority of children in Russia. The drug has shown high efficacy in the treatment of ALL in both our and other international protocols. Registration of the drug will allow children with ALL to freely receive life-saving therapy throughout the country, "said Alexander Grigoryevich Rumyantsev, academician of the Russian Academy of Sciences, professor, president of the Federal State Budgetary Institution" National Medical Research Center for Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev "Ministry of Health of Russia, Chief Oncologist.

In 2018, Servier acquired the Shire oncology portfolio, including exclusive rights to the Oncaspar drug and related technological processes. The registration of the drug Onkaspar (solution for intramuscular and intravenous administration), which was previously in force in Russia, was canceled on August 13, 2019 according to the statement of the holder of the corresponding registration certificate Medak GmbH (Medac GmbH, Germany). The registration of the new dosage form of the original pahaspargase (lyophilisate for the preparation of a solution for intramuscular administration and infusions) is due to the cessation of production of the previously used dosage form (solution for intramuscular and intravenous administration).