WHO classifies Bedaquiline as 'priority' anti-TB drug

Contentious drug bedaquiline, which is in high demand for tuberculosis (TB) treatment but is not easily available, has been placed in the list of 'priority' drugs by the World Health Organisation (WHO). This was stated in a communication from WHO, which BusinessLine has accessed.

In previous guidelines Bedaquiline was placed in 'Group C,' which indicates drugs that can be used 'when agents in Group A and B cannot be used,' that is when patients develop resistance to these drugs

The communication states that bedaquiline has been placed in 'Group A' – medicines to be prioritised – along with levofloxacin/ moxifloxacin.

WHO, however, warns that it does not have evidence on the safety and effectiveness of bedaquiline use beyond six months, as it was insufficient for review. Also, linezolid, a highly potent drug with severe side-effects, including temporary or permanent loss of hearing, may limit its use, WHO says.

In a substantial revision of guidelines since 2016, the communication states that WHO no longer recommends use of kanamycin and capreomycin for TB patients due to the increased risk of treatment failure and relapse associated with their use. It states that countries should not wait for existing stocks of Kanamycin to be exhausted and should immediately replace it with the relatively safer – amikacin, in the shorter regimen. Kanamycin use is discouraged due to instances of ototoxicity causing hearing loss.

Currently, US-based Johnson and Johnson's (J&J) Janssen holds the patents for producing bedaquiline, until 2023. Under the conditional access programme of the Indian government, bedaquiline imported from Janssen is being administered to close to 1,000 patients in the country. By the Central Government’s own admission, over 2,000 patients require the drug, though experts say that the number may be much more, closer to 20,000 patients.

There has been no official survey of how many patients need the drug, and it is supposed to be administered on a need basis. Even as there are 1.3 lakh estimated drug-resistant patients, bedaquiline is not to be given to children, pregnant or lactating mothers.

J&J recently announced a price reduction for bedaquiline in some countries, including India. India has received the current stock through donations, but once it decides to scale up, it will have to start buying the drugs from J&J under the aegis of the Global Drug Facility.

“J&J falls short in terms of making the drug affordable in countries that are hardest hit by DR-TB. The reduced price of $400 for six months of treatment that certain countries are promised, remains excessive. In countries excluded from J&J’s price reduction, the corporation currently charges between $3,000 and $30,000 for six months of treatment,” said a statement released by Doctors Without Borders (MSF).

On the patent battle, the statement says, “To ensure the long-term affordability and sustainable supply of bedaquiline — which is patented quite widely until 2023 — MSF called on J&J to also issue a licence to the Medicines Patent Pool, which would enable access to affordable generic versions of the drug.”