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First New Antibiotic for Drug-Resistant TB Approved In 50 Years

The problem of treating tuberculosis has been increasing in the past few decades due to drug-resistant strains. To overcome this, scientists across the world are working to find new drugs that can help fight the menace of tuberculosis. In light of this, the first new antibiotic for drug-resistant tuberculosis has been approved in 50 years by US-FDA on 14 August 2019.

Why it is important?

It is a well-known fact that tuberculosis is a global disease with cases in almost every country. It is an airborne disease caused by Mycobacterium tuberculosis which mainly affects the lungs but can also spread to other parts of the body.

Around more than 10 million people got infected with TB and approximately 1.6 million people lost their lives in 2017. World Health Organisation (WHO) has reported half a million cases of drug-resistant tuberculosis across the world. The studies also show that almost 1 in 3 deaths occur due to the drug-resistant form of the bacteria. These figures highlight the importance of this development which has proven to be a victory for patients suffering from tuberculosis.

Why need of new antibiotic?

Initially, there have been drugs for treating tuberculosis but soon the TB bacteria gained antibiotic resistance for these drugs. This made the condition worse and to overcome this situation combinational therapy was implemented. In this therapy, a combination of two or more drugs is used to fight the infection. However, the infectious bacteria soon became resistant to a few of these drugs too. Such infection, where an individual is infected with bacteria resistant to multiple (two or more) drugs is known as MDR-TB (Multiple Drug-Resistant Tuberculosis). Similarly, when the bacteria becomes resistant to four core antibiotics for tuberculosis, the condition is known as extensively drug-resistant tuberculosis (XDR-TB). In light of this, scientists all over the world started working on developing new drugs to overcome the perils of tuberculosis.

In 2002, TB Alliance – A famous non- profit organization took the responsibility of developing a drug for XDR-TB, which is now approved by the FDA. The drug named “Pretomanid” will soon be in the market for use in the selected population.

Three Drug Regimen to treat TB – Clinical Trials

The three-drug regimen includes Bedaquiline, Pretomanid, and Linezolid, which is also stated as BPaL regimen. This is a combination therapy wherein these drugs will be used together to treat patients with XDR-TB.

To study the effect of these drugs in combination clinical trials were conducted in South Africa. The Nix-TB trial enrolled around 109 people suffering from extensively drug-resistant TB as well as those suffering from non-responsive MDR-TB.

The results of the clinical trial showed that almost 95 patients showed a positive outcome after 6 months of treatment with a three-drug regimen. For some patients, the treatment was also extended for a few more months to see the response. More trials have been conducted in 14 countries to evaluate the safety and efficiency of Pretomanid drug among TB patients.

Knowing the new antibiotic- Pretomanid

Pretomanid is presently a third new drug against tuberculosis that has been approved by the FDA in 50 years. It is also a first drug that is developed by a non-profit organization (i.e. TB Alliance). It is stipulated that by the end of 2019 the drug will be in the United States market.

TB Alliance has licensed a Mylan NV – a pharma company in Pennsylvania for manufacturing and selling the drug. Presently, the focus will be on availing the drugs in the country like United States and other areas with high cases of XDR-TB. The majority of these countries are developing countries and low-income markets.

Way Ahead

It is evident from the rising cases of TB across the world that the development of new drug Pretomanid cannot be more timelier. The recovery of 90 percent of patients in the clinical trials gives a ray of hope. The efforts of TB Alliance must be recognized as it is a non-profit organization i.e. there will be no claim of the profits which will make the drug more affordable.

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