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  5. A Change in the Treatment of Multidrug-Resistant Tuberculosis Begins New Antituberculosis Drug Deltyba® in 50 mg Tablets, Available to Patients in Japan Starting September 26

September 8, 2014

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

A Change in the Treatment of Multidrug-Resistant Tuberculosis Begins
New Antituberculosis Drug Deltyba® in 50 mg Tablets, Available to Patients in Japan Starting September 26

  • Deltyba®, discovered and developed at Otsuka Pharmaceutical, is the first new antituberculosis drug to debut in Japan in 40 years, and is the only drug in Japan approved specifically for multidrug-resistant tuberculosis (MDR-TB). Used in conjunction with an optimized background treatment for MDR-TB in line with WHO recommendations, Deltyba represents a new therapeutic option in Japan for this disease. New medicines for MDR-TB are needed to help shorten hospitalizations and decrease mortality.
  • With approximately 20,000 TB patients, Japan has the highest incidence of TB among the most developed countries. During the initial phase of treatment when patients with active TB may be contagious and therefore a risk to public health, they must be quarantined in hospital. The inability to work or be with their families during this time may create a great deal of stress and suffering. Patients with MDR-TB who are being retreated with existing medications are particularly vulnerable to developing resistance, which may lead to poorer treatment outcomes, including death. This is why new MDR-TB medications with novel mechanisms of action are so urgently needed.
  • As Mycobacterium tuberculosis may develop resistance to new medications if they are misused or if treatment is interrupted, Otsuka Pharmaceutical is initiating a responsible access program (RAP) to help ensure rational use of Deltyba so that it may remain a viable treatment option for the future. The plan includes supply of the drug to registered health care institutions capable of performing precise drug sensitivity tests.

Tokyo, Japan (September 8) - On September 26, Otsuka Pharmaceutical will begin sales in Japan of a new antituberculosis drug, Deltyba in 50 mg tablets (generic name: delamanid), indicated for adults with pulmonary multidrug-resistant TB. Deltyba has a novel mechanism of action, exhibiting bactericidal properties by inhibiting mycobacterial cell wall biosynthesis, essential for the cellular walls of Mycobacterium tuberculosis. It is approved for use in patients with MDR-TB (defined as resistance to isoniazid and rifampicin) when other treatment options are limited. Deltyba has been designated by the MHLW as an orphan medicine for treatment of a rare disease.

Status of MDR-TB in Japan
In spite of having decreased after World War II, the incidence of tuberculosis in the Japanese population is 17 out of every 100,000 people, the highest level among the most developed countries. Resistance to an antituberculosis drug arises when the drug cannot be used properly because, for example, side effects interfere with carrying a treatment regimen through to completion. Treatment of MDR-TB has consisted of simultaneous use of multiple older antituberculosis drugs. However, the effectiveness of this approach has been poor and has necessitated treatments of at least 20 months duration and in some cases for several years. Without a new drug, the effectiveness of therapy has failed to improve, with therapeutic success estimated between 40 and 70 percent. Infection with MDR-TB can be prolonged and high mortality is a serious problem (three-year mortality is 18 percent and five-year mortality is 25 percent).


Information in this news release was current as of the original release date.

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