Japan-based Otsuka Pharmaceutical has received marketing authorisation from the European Commission for Deltyba (delamanid) to use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Deltyba is a bactericidal agent with a new mode of action that interferes with the metabolism of the Mycobacterium tuberculosis (MTB) cell walls and it also has high activity in-vitro against several MTB strains, including those resistant to first-line anti-TB drugs, such as isoniazid and rifampicin.
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By GlobalDataAccording to the clinical trial results from nine countries, patients treated with Deltyba 100mg twice-daily together with an optimised background regimen (OBR) achieved a statistically significant increase in sputum culture conversion (SCC) after two months compared with placebo.
The company said that SCC is a measurement used to determine when a patient is no longer infectious.
Otsuka chairman Akihiko Otsuka said the company is happy that the newly develop drug has become available to patients in Europe with MDR-TB.
"Currently, MDR-TB is a serious problem there," Otsuka said. "When rifampicin was developed half a century ago, it seemed that the world’s TB problem was over.
"But I specifically selected TB as a research theme for our company. I knew that someone had to do this research because TB was still a huge public health issue in Asia."
According to the company, resistance to anti-TB drugs can occur for a number of reasons such as misuse or mismanagement, failure to complete a full course of treatment due to potential side effects.
University Medical Center in Groningen MDR-TB expert Wiel de Lange said the TB community has waited a long time for a new medication for MDR-TB.
"With increasing rates of resistance to existing medications and globally less than half of all MDR-TB cases successfully treated, Deltyba is clearly a welcome new option," de Lange said.
Globally, the success rate of MDR-TB treatment is less than 50% and treating patients using only existing anti-TB drugs has created an urgent unmet medical need.
Otsuka Pharmaceutical president Taro Iwamoto said the company is happy that Deltyba has been granted a marketing authorisation as a first-in-class, anti-TB drug in Europe.
"There are still many patients throughout the world who suffer from MDR-TB. I hope Deltyba will contribute to the improvement of TB treatment," Iwamoto said.
In order to ensure that in the future patients can continue to benefit from Deltyba, the company has invested in the creation of a responsible access programme (RAP) to help safeguard against the possible emergence of resistance to the medicine.
Image: Dyed magnification of tuberculosis bacteria. Photo: courtesy of Business Wire.
