FDA Puts Partial Hold on Tests of Ipsen Drug Acquired in $1B Deal
Summary
FDA Puts Partial Hold on Tests of Ipsen Drug Acquired in $1B Deal Two clinical trials testing an Ipsen drug in rare connective tissue disorders have been placed on partial hold after safety concerns about chronic dosing of the compound emerged. But the Paris-based company, which has US operations in Cambridge, MA, says the FDA is permitting studies to continue testing the drug in patients 14 and older. Ipsen brought palovarotene into its pipeline earlier this year through the acquisition of Montreal-based Clementia Pharmaceuticals for $1 billion up front. The Ipsen drug is being tested as a treatment for fibordysplasia ossificans progressiva (FOP), a condition in which muscle and connective tissue are gradually replaced by bone. Ipsen said Friday that the FDA issued partial holds on both clinical trials after the company submitted safety reports to the agency concerning cases of early growth plate closure in the Phase 3 study testing chronic dosing of palovarotene in FOP patients.
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