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K-V preterm birth drug approved

K-V Pharmaceutical's Makena has received US approval as the first drug indicated to reduce the risk of preterm birth in women pregnant with one child who have a history of spontaneous preterm birth

The US Food and Drug Administration (FDA) has granted marketing approval for K-V Pharmaceutical's Makena (hydroxyprogesterone caproate) as the first drug indicated to reduce the risk of preterm birth in women pregnant with one child who have a history of spontaneous preterm birth.

One in eight babies in the US is born at less than 37 weeks gestation, and the rate of preterm birth has increased more than 35 per cent in the last 25 years, according to figures from March of Dimes – a US charity concerned with improving the health of babies.

Makena, which was formerly known as Gestiva, is given as an intramuscular injection by a healthcare professional every seven days beginning between 16 and 20 weeks of pregnancy and continuing until 37 completed weeks or until delivery, whichever comes first. The drug is not intended for use in women with a multiple pregnancy or other risk factors for preterm birth.

Under the FDA's accelerated approval programme, marketing clearance was granted based on the surrogate endpoint of improvement in the proportion of women who delivered at less than 37 weeks of gestation, in spite of the fact that there are no controlled trials demonstrating a direct clinical benefit for the drug, such as improvement in neonatal mortality and morbidity.

The approval study included 463 women 16 to 43 years of age who were pregnant with a single foetus and had a history of a prior spontaneous preterm birth. Thirty-seven per cent of women treated with Makena delivered before 37 weeks, compared with 55 per cent of women in the control group.

An international trial is ongoing to determine whether Makena reduces the number of babies who do not survive or who suffer serious health problems shortly after birth.

Under a pre-existing agreement, worldwide rights to Makena are expected to be transferred to K-V from Hologic, the product's developer, within the next five days. K-V will make a $12.5m cash payment to Hologic before the transfer, in addition to the $79.5m payment and reimbursement of various expenses to Hologic that it has already made under the 2008 agreement. K-V is also required to make additional payments to Hologic totaling $107.5m over the next 30 months, for a total purchase price of $199.5m.

K-V intends to market the product through its Ther-Rx Corporation subsidiary. Ther-Rx will also be responsible for launching and maintaining the Makena Care Connection, a programme for patients and healthcare providers that offers administrative, financial, and treatment support for Makena.

7th February 2011

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