Axelpharm received an AU for the drug Osimertinib (INN osimertinib). The drug is indicated as a therapy for non-small cell lung cancer in the presence of a mutation in the EGFR gene in tumor cells. Axelpharm fulfiled documents for registration of the drug in December 2020. In 2021, AstraZeneca sued Axelpharm for patent infringement on ‘Osimertinib’. The Eurasian patent for the original drug from AstraZeneca “Tagrisso” is valid until 2032.
Osimertinib is an irreversible EGFR tyrosine kinase inhibitor effective in the presence of sensitizing mutations in the EGFR gene and the T790M mutation associated with the development of resistance to tyrosine kinase inhibitors. According to the phase III ADAURA clinical trial, the drug reduces the risk of recurrence or death by 80% when used as adjuvant therapy for early-stage non-small cell lung cancer with mutations in the EGFR gene.
Axelpharm is the owner of registration certificates for three more drugs. These include the cancer-fighting drug bosutinib, the immunosuppressant tofacitinib, and ibandronic acid (a bisphosphonate used to treat bone disease).
