European approval for new drug against highly resistant TB

The European Commission has given conditional market authorisation for the three-drug, six-month, all-oral regimen for the treatment of highly resistant tuberculosis (TB). KNCV Tuberculosis Foundation was closely involved in the preparations for in-country application of this regimen. “This is a very important development in the fight against TB. We look forward to assisting countries introduce and scale up this treatment, which can save many lives,” says Agnes Gebhard, technical director of KNCV.

This regimen is known as BPaL and consists of the drugs bedaquiline, pretomanid and linezolid. Pretomanid is a new drug against TB, developed by the non-profit TB Alliance. The combination of these three oral medications means that patients with highly resistant  forms of TB no longer need to undergo painful injections for months. Moreover, treatment with BPaL takes “only” six months, as opposed to the 18 to 24 month treatment currently recommended for patients with highly resistant TB. But most of all, the new regimen offers a much greater chance of a cure. Until recently the cure rate of extensively resistant TB was only 34 percent worldwide; the BPaL regimen succeeded in curing 90 percent of the patients under treatment.

Previously, the BPaL regimen also received approval from the United States Food & Drug Administration (FDA). European approval is an important next step in the fight against the most deadly infectious disease in the world. After all, 1.5 million people still die from TB every year. This is not necessary, because in most cases the disease can be cured with a combination of 4 drugs, taken for 6 months. Resistant TB is more difficult to treat because one or more of the antibiotics are no longer effective.

Gebhard: “The BPaL regimen offers new hope to cure more people with highly resistant TB. Now we need to ensure that patients who need these medicines can receive these from their physicians. We are committed to assisting countries to realize patients’ access to this new regimen.”

Increase accessibility of BPaL regimen

In recent years, KNCV has worked on introducing and scaling up the use of new medicines and regimens in over 20 countries. As a partner of the TB Alliance, KNCV conducted studies into the expected acceptance and costs of the new BPaL regimen in Indonesia, Kyrgyzstan and Nigeria.

KNCV is already supporting implementation of projects to start the use of BPaL under appropriate conditions in Nigeria, Ukraine and Tajikistan; also in eight other countries, KNCV assists in planning and mobilizing the necessary finances to enable the introduction of this shorter treatment without injections.

PHOTO CREDIT: Olivier Le Blanc