(Reuters) – Independent experts of an FDA advisory panel voted in favor of the not-for-profit TB Alliance’s treatment for drug resistant tuberculosis, as a part of a three-drug combination regimen.
The panel on Tuesday 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 U.S. health regulator is not bound to follow the advice of its advisory panels, it usually does so.
MDR-TB and XDR-TB are forms of tuberculosis that do not respond to first-line anti-TB drugs. MDR-TB does not respond to even isoniazid and rifampicin – the two most powerful anti-TB drugs.
More than half a million cases of MDR-TB are reported across the world every year, according to the Centers for Disease Control and Prevention (CDC).
TB Alliance has granted a license 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 U.S. and EU after getting approval, a company spokeswoman told Reuters.
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.
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 favor, said.
The FDA is expected to make a final decision on pretomanid’s approval by the third quarter of 2019.
(Reporting by Manojna Maddipatla and Tamara Mathias in Bengaluru; Editing by James Emmanuel)
