Why China doesn’t ban Delamanid use

Delamanid is a new anti-tuberculosis drug specifically designed to treat multidrug-resistant tuberculosis (MDR-TB). In the global tuberculosis prevention and control system, drug-resistant tuberculosis has always been difficult to treat. Traditional drugs have limited efficacy and severe side effects. As one of the countries with a high incidence of tuberculosis in the world, China is extremely cautious about the introduction and use of new drug-resistant tuberculosis drugs, but it has not banned the use of delamanid. The reasons mainly involve public health needs, drug efficacy and safety, and national drug regulatory strategies.

First, from a public health perspective, the high incidence and contagiousness of drug-resistant tuberculosis makes controlling such diseases a national priority. If MDR-TB patients cannot obtain effective drug treatment, not only will their condition be difficult to control, but they may also increase the risk of tuberculosis transmission in the community and families. As a new drug that can effectively inhibit drug-resistant Mycobacterium tuberculosis, the introduction of delamanid can help increase the sputum negative conversion rate and shorten the pathogen clearance time, thereby reducing the risk of infection. Banning the use of such drugs may delay the control of drug-resistant tuberculosis and is not in the interest of public health.

Secondly, delamanid has shown clear efficacy and safety in clinical studies. In adults and childrenMDR-TB patients, combined treatment with delamanid can significantly improve the rate of pathogenic negative conversion and is well tolerated. Before approving the drug for marketing, the domestic drug regulatory authorities strictly evaluated its pharmacokinetic properties, safety and efficacy data to ensure that the drug is suitable for clinical application. This means that regulatory agencies recognize the use value of Dramani, rather than prohibiting its listing and application.

In summary, China does not ban the use of delamanid based on comprehensive considerations of public health needs, scientific efficacy evaluation, and drug management regulations. Its launch and application not only fill the gap in the treatment of drug-resistant tuberculosis in China, but also conform to the latest international trends in the management of drug-resistant tuberculosis, providing patients with a safe, effective and controllable treatment option.

Reference: https://go.drugbank.com/drugs/DB11637