What is Bedaquiline, the tuberculosis drug that goes off-patent in July

The Indian Patent Office has denied Johnson and Johnson’s request to extend the patent on a crucial tuberculosis drug called Bedaquiline, allowing local companies to make less expensive generic versions.

According to the WHO’s 2022 Global TB report, India accounted for over 29 percent of the 10.6 million tuberculosis infections worldwide, a significant public health issue as it battles drug-resistant strains.

The  generic production of Bedaquiline can start after its  patent expires in July 2023. This will significantly lower the price and make the medication accessible to the society’s most marginalized groups.

What is Bedaquiline?

It is one of the most critical drugs to treat tuberculosis, and it is approved for the treatment of drug-resistant tuberculosis (MDR-TB). A type of antibiotic, it works by preventing the TB-causing bacteria’s ability to produce an enzyme, hence halting the growth and spread of the bacterium. It was developed by Janssen Therapeutics, and the US Food and Drug Administration (FDA) approved it in 2012 for the treatment of multidrug-resistant tuberculosis. Bedaquiline was prioritized among drugs for treating MDR-TB in a 2018 WHO Rapid Communication on MDR-TB treatment guidelines. 

As an essential part of a comprehensive TB treatment strategy, bedaquiline is given as a tablet and is typically taken daily for several months. It has a number of benefits, one of which is its ability to be used alongside other antibiotics to treat MDR-TB, which can improve the efficacy of the regimen. Bedaquiline should only be used under the close supervision of a healthcare provider due to the serious negative effects it can have, including a higher risk of cardiac problems. It has been associated with an increased risk of abnormal heart rhythms, which can be life-threatening.

Despite these concerns, Bedaquiline has been found to be effective in treating MDR-TB and it has grown to be a key weapon in the fight against drug-resistant TB. Research is being done to examine how it might be used to treat different strains of TB and other bacterial infections in addition to MDR-TB.

A combination of medicines that are taken for several months is the conventional treatment for TB. With the development of drug-resistant TB strains, it is far more challenging to treat MDR-TB, a kind of TB that is resistant to at least two of the main TB medications, isoniazid, and rifampicin. MDR-TB patients need longer, more involved treatment plans that are often less effective and potentially have greater adverse effects.

Clinical trials have proven the efficacy of bedaquiline, which was created specifically to treat MDR-TB. After receiving FDA (Food and Drug Administration) approval in the United States in 2012, it has since received approval in other countries as well.

The price of bedaquiline presents a major challenge. Being a relatively new drug, it remains protected by a patent, which makes it potentially expensive. However, the new decision by the Indian Patent Office has paved the way for some generic versions of the medication, which might make it more available and cost-effective for patients in low- and middle-income nations.

Impact on the treatment

The original J&J medication is currently only available through the government and costs about Rs 21,000 for a six-month course. The government may be able to make this drug available to the underprivileged population after the cost decreases as a result of generic versions.

The Hindu Businessline’s Senior Deputy Editor G Naga Sridhar in a podcast said that this decision is a significant development because this opens up the doors for Indian pharma companies to make generic versions of this drug, which is a key component of the treatment for drug resistant TB patients. 

“In the case of India this is an important development because there are 21 lakh TB patients in India, according to WHO TB report 2021 and a substantial number of them are seen as drug resistant patients. So obviously, this would bring down the cost once the generic versions of the drug are coming in,” he added.

Also Read: Developing medication that treats Tuberculosis in 3 months: Bill Gates