Independent experts of a US Food and Drug Administration advisory panel voted in favour of the not-for-profit TB Alliance’s treatment for drug resistant tuberculosis, as a part of a three-drug combination regimen. Reuters Health reports that the panel voted 14-4 when asked to assess the treatment, pretomanid, in combination with Johnson & Johnson’s bedaquiline and linezolid for multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB).
Although the US health regulator is not bound to follow the advice of its advisory panels, it usually does so. More than half a million cases of MDR-TB are reported across the world every year, according to the US Centres for Disease Control and Prevention (CDC).
The report says TB Alliance has granted a licence to Mylan NV in April to manufacture and sell pretomanid as part of certain regimens in high-income markets and a non-exclusive license in low-income and middle-income countries where most tuberculosis cases occur.
Although the drugmaker immediately targets countries with high rates of XDR-TB, it will also sell the drug in both the US and EU after getting approval, a company spokesperson is quoted in the report as saying.
The report says the FDA granted priority review for pretomanid and the marketing application is based on interim data from the first 45 patients in an ongoing study with a total of 109 participants.
“I am impressed with the outcome from the 45 individuals who have completed the study, but I think at the best they are preliminary data and not enough for me to be able to conclude that this is substantial,” Ighovwerha Ofotokun, a panel member, who voted against the approval, said.
The report says patients treated with the drug highlighted the need for a shorter treatment regimen for the condition, which is typically treated over years with a cocktail of antibiotics.
The current treatment for the condition that involves eight or nine drugs along with multiple injections is difficult for patients. Therefore, “having a three-drug oral regimen will be a benefit,” Philip LoBue, a panel member who voted in favour, said.
The report says the FDA is expected to make a final decision on pretomanid’s approval by the third quarter of 2019.
[link url="https://www.reuters.com/article/us-tb-alliance-fda/fda-advisory-panel-recommends-approval-of-tb-alliances-tuberculosis-treatment-idUSKCN1T72QP"]Reuters Health report[/link]