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The Food and Drug Administration’s
Anti-Infective Drugs Advisory Committee approved a pharmaceutical company’s
request for accelerated approval of the drug bedaquiline to treat TB, in spite
of concerns about an imbalance of deaths in clinical studies.
Johnson &
Johnson’s Janssen Research & Development had requested the accelerated
approval—a type of temporary approval based on less clinical data than is
usually required for traditional drug approvals—on the drug as a treatment for
drug-resistant TB. The panel of non-FDA medical experts reviewed the proposal
on November 28; they voted 18 to 0 for approval, arguing that there was
“substantial evidence” that bedaquiline was effective, and 11 to 7 in favor of
a similar safety question. Panel members were divided on whether the drug
contributed to the deaths that were seen in clinical studies.
Representatives from the
pharmaceutical company said that if the drug was approved, they would propose
making it available only through public health agencies in the United States to
limit its use to patients with drug-resistant TB. Only about 100 cases of
drug-resistant TB are seen in the United State, but the problem is more
widespread in developing countries.
Data from the Phase 2 clinical
studies of bedaquiline suggested that it killed TB bacteria faster than the
placebo. All patients in the trial received other drugs used to treat TB. There
were more deaths among the patients treated with bedaquiline. Most of the
deaths were attributed to the underlying TB disease. An FDA medical reviewer
stated that in some of the deaths, a contributory role of bedaquiline, when
combined with other drugs used to treat TB, could not be ruled out. Also, there
was not enough data for the FDA to rule out potential side effects on the liver
and heart.
FDA officials said that information
from the larger, planned clinical studies is needed to get a better idea of the
drug’s safety profile. Janssen will begin a larger study early in 2013. The
data from that study will have to be submitted to the FDA to get regular
approval of bedaquiline. Also, the FDA has the power to rescind the accelerated
approval if additional data suggest a safety problem or do not show a benefit.
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