FDA panel to weigh Adeza’s pre-term birth drug
By Susan Heavey
WASHINGTON (Reuters) – The U.S. Food and Drug
Administration is set to ask a panel of outside experts whether
more studies are needed for Adeza Biomedical Corp.’s Gestiva
drug to show if it is safe and effective to prevent early
births, according to documents released on Monday.
Data submitted by Adeza on the drug’s effectiveness was at
odds with an earlier study, FDA staff said in documents
released ahead of the meeting. It also showed a possible
increase in miscarriages and stillbirths in women who used it.
The FDA advisory panel on Tuesday will weigh whether to
recommend Gestiva for women who have a history of giving birth
too early. The FDA will make the final decision, but usually
follows the advice of its panels.
Adeza shares were off 5.3 percent at $14.91 in afternoon
trading on Nasdaq following release of the FDA staff report.
Gestiva is a long-lasting, injectable form of the hormone
Overall, the company’s study showed “a statistically
significant reduction” in preventing pre-term births, FDA staff
But they added the FDA would ask panelists whether another
trial would be needed to confirm the company’s trial, which
found 36 percent of women taking Gestiva gave birth too early,
compared with 55 percent of women who did not take it.
A previous study found 37 percent of women not taking
Gestiva experienced pre-term birth, FDA staff said. Both
studies were government-funded. Another company study found 36
percent of untreated women gave birth early, according to the
There were no reported maternal deaths, the FDA added.
Pre-term delivery — at less than 37 weeks of pregnancy —
is a growing trend in the United States, where about 12 percent
of all babies are born prematurely, according to the March of
Dimes baby health advocacy group.
Women who have had a premature baby before, or are carrying
two or more babies, or have certain reproductive abnormalities
are at greater risk, the group says. Certain behaviors such as
smoking or drinking alcohol as well as some diseases such as
diabetes can also increase the risk of premature birth.
While there is no FDA-approved drug to prevent early
births, the agency said many pharmacists have been compounding
the drug on their own and doctors also use other drugs that are
known to stop contractions but lack FDA approval to prevent
Adeza, in a separate document released on Monday, said
getting FDA approval was crucial to provide consistent
information on dosing, ensure consistent drug quality and
provide broader availability, among other reasons.
“Given the clear unmet need and the highly favorable
benefit/risk ratio, the case for approval … is compelling,”
the company said.
Prolonging the time a baby is in the womb by as little as
one week would improve a baby’s health and increase its chance
for survival, Adeza officials added, citing the high costs of
caring for premature babies.
A 2003 March of Dimes report estimated that U.S. hospitals
spent $36.7 billion on infants and half of that — $18.1
billion — was directed at those born to soon or too small.
The FDA said it would also ask its advisers if more studies
are needed to weigh whether the drug was associated with higher
miscarriage and stillbirth rates.
Additionally, it said it would ask whether data on
preventing births before 37 weeks of pregnancy would be
adequate. The company study did not persuasively show Gestiva
could prevent births before 35 weeks and 32 weeks of gestation,
both of which are better indicators of infant death, the FDA