Pharmaceuticals firm Shire has withdrawn its licence application for the Fabry disease treatment, REPLAGAL, with the US Food and Drug Administration (FDA).
Fabry disease is a rare enzyme deficiency condition which can result in "full body" pain and kidney failure.
Shire says the FDA encouraged it to submit an application, with the implication being that approval could be fast tracked.
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The company now says recent communication with the agency has suggested further controlled trials would be required before a licence could be granted, the costs of which Shire seems unwilling to take on.
REPLAGAL has been cleared for use in the European Union for 10 years.
The news saw Shire shares drop 1.66% by 11:46.
In a separate announcement Dublin based Shire said it would buy the Californian firm Ferrokin Biosciences for an upfront payment of $100m, payable in cash at closing, plus potential post-closing milestone payments of up to $225m.
The transaction will give Shire control over FerroKin's FBS0701. It may not be the most snappily named drug but can be easily described as a once-a-day oral capsule for the treatment of iron overload due to chronic blood transfusions.
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