What are the chances of Dovprela's successful benefits?

Conditionally passing the committee,

The first new drug in 50 years, it's not a big profit

Attention is focusing on whether the new tuberculosis drug Dovprela, which appeared in 50 years, can be listed on the insurance benefit list.

 

According to related industries, Viatris Korea's Dovprela passed the HIRA Pharmaceutical Benefit Evaluation Committee on the 1st.

 

Dovprela, which was approved in Korea in October last year after U.S.

 

approval in September 2019, can be used as a combination of three types of therapy with Bedaquiline and Linezolid in adult patients with extensive drug-resistant pulmonary tuberculosis, treatment-resistant or non-reactive multidrug-resistant tuberculosis.

 

This drug is the first new treatment in more than 50 years.

 

The TB treatment market has been shunned by front-line pharmaceutical companies for its poor drug economy.

 

Dovprela is a drug created through collaboration with a non-profit organization called "TB Alliance" with Viatis.

 

Multidrug-resistant tuberculosis is resistant to two or more tuberculosis treatments, including Isoniazid and Rifampicin, which are the two most effective anti-tuberculosis drugs for tuberculosis treatment, and is not treated with the treatment.

 

The causes of the outbreak are divided into primary resistance and acquisition resistance, which are infections with resistant tuberculosis bacteria from the beginning, and acquisition resistance is when resistance is acquired during treatment due to arbitrary discontinuation of drug use and irregular administration.

 

Multidrug-resistant tuberculosis has a treatment success rate of only about 50%, so the treatment efficiency is low, and secondary drugs used for treatment have more side effects than primary drugs.

 

Since the treatment period is also long, 18 to 24 months, the cost burden is high, and in some cases, lesions must be removed through surgery.

 

The combined treatment of seven drugs, including Bdq, which are currently used in the standard treatment of multidrug-resistant tuberculosis, is not well used in Korea due to its high drug resistance rate, and the treatment period is still 9-12 months, making it difficult for patients to manage medication and the treatment failure rate high.

 

Dovprela demonstrated its efficacy through a phase 3 clinical Nix-TB study.

 

Dovprela is a combination of three treatments (BPaL) with Bedaquiline and Linezolid, showing a successful treatment effect of 92% in the multidrug-resistant tuberculosis group and 89% in the broad drug-resistant pulmonary tuberculosis group in six months, confirming its potential as a new short-term combination therapy.

 

The existing treatment period of 18 to 24 months was shortened to 6 months, and within 16 weeks, almost all patients with drug-resistant pulmonary tuberculosis and multidrug-resistant tuberculosis were confirmed to have sputum culture negative.

 

BPaL therapy is a combination of ready-to-use therapy consisting only of oral drugs, with fewer drugs than the treatment guidelines recommended to administer at least four drugs to intensive care units, and showed complete data in about 90% of patients with extensive drug-resistant tuberculosis during 6-month treatment.