The first three series of Deltyba (delamanid), a therapy for drug-resistant tuberculosis, exceeding 11,000 packages, are ready for shipment to regional medical institutions. R-Pharm’s medicinal product has passed the entry into civil circulation procedure, including additional testing with the involvement of an independent laboratory of Roszdravnadzor.
Deltyba was developed by Japanese company Otsuka Pharmaceutical Co., Ltd., and is currently produced by the R-Pharm group of companies. Thanks to the close cooperation between Russia and Japan, Deltyba became the first medicine to undergo the new registration procedure established by the rules of the Eurasian Economic Union. In February 2021, the commission of the Ministry of Health of the Russian Federation recommended Deltyba for inclusion into the list of vital and essential medicines.
“As part of the strategic cooperation of the R-Pharm group of companies with Japanese partners, we continue to provide Russian patients with access to new health protection technologies. We are confident that Deltyba, a therapy for the treatment of multidrug-resistant tuberculosis, will contribute to improving the situation with this dangerous disease in our country,” said Mikhail Samsonov, medical director of the R-Pharm Group of companies.
Deltyba (delamanid) is a new oral therapy with bactericidal activity against Mycobacterium tuberculosis, including against MDR strains, for the treatment of pulmonary tuberculosis in adults.
Delamanide eliminates bacilli significantly faster as part of the combined treatment of pulmonary MDR-TB of the lungs in adult patients compared to the scheme without delamanide. The use of the drug together with other registered anti-tuberculosis drugs does not result in cross-resistance, which makes it possible to include it in standard and individual IV regimens for pulmonary MDR-TB ltherapy in adult patients.
Delamanide has favorable safety profile, and its use has already been described for a number of additional groups of patients, including people with HIV.
Deltyba was previously approved in more than 40 countries around the world, including the European Union, Hong Kong, India, Japan, China, and others.