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 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.
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"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)
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