Ukraine will have access to the most advanced drug against tuberculosis
Ukraine will have access to a modern drug for the treatment of severe forms of tuberculosis, which were considered incurable disease until now. The talks between Janssen and Pharmstandard about access of Bedaquiline to Ukraine have end in success. In January Janssen Pharmaceuticals, Inc. will begin the registration process of the drug in Ukraine.
After numerous appeals from the Network and the AHF, supported by the Centre for Public Health of the Ministry of Health of Ukraine, regarding the need to return the Ukrainian market under the supervision of Janssen, Pharmstandard and Janssen came to an agreement last week.
“The Network repeatedly sent written and oral applications to the representatives of both companies and finally they followed our request,” said the Policy and Advocacy Director Serhiy Dmitriev, “This is an extremely important event for many serious patients of Ukraine suffering from tuberculosis! Given the high cost of the drug, the Network will seek to make Bedaquiline to be affordable through government programmes.”
We would like to recall that Bedaquiline is an important drug for the treatment of multi-resistant tuberculosis, especially among those patients who have no other options for treatment. According to experts’ estimates, about 2 000-2 500 patients need treatment with Bedaquiline in Ukraine. However, due to the developer company Janssen which transferred its exclusive trade rights in Ukraine to the Russian company Pharmstandard, the Bedaquiline’s registration and enter to the Ukrainian market was significantly complicated.
Over the past 40 years, Bedaquiline became the first new drug for the treatment of multiple-drug resistant tuberculosis (MDR-TB) which has received rapid approval from the FDA. Studies have shown that this drug is particularly effective against multi-resistant strains of mycobacterium tuberculosis. It reduces the time required for negative analyzes by one third and also increases the proportion of participants with negative analyzes in 6 months from 58% to 79%.