The French pharmaceutical group Ipsen announced Friday the withdrawal of its request for approval in the United States of palovarotene, a flagship molecule of its strategy, following discussions with the United States Medicines Agency (FDA).
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Palovarotene is in development as a potential treatment for rare bone diseases such as progressive ossifying fibrodysplasia (PFO), an extremely disabling condition.
Additional data analyzes expected
The third French laboratory and the FDA agreed on the fact “that further analysis and evaluation of the data collected from the MOVE Phase III trial and Ipsen’s FOP program would be required“, According to a press release from Ipsen.
Ipsen adds to have “the firm intention to resubmit the palovarotene data for review as soon as possibleSays Howard Mayer, executive vice president and director of research and development at Ipsen. The new request for approval will be submitted “once the additional data analyzes have been completed», Specifies the laboratory.
Ipsen got his hands on the molecule in early 2019 by buying the Canadian biotech Clementia for $ 1.3 billion. At the time, the French group said it was banking on approval from 2020 in the United States, which should pave the way for a commercial launch in 2020 on the American market and then in Europe.
This is a new setback for Ipsen with palovarotene, because the laboratory had already announced that it was partially suspending its clinical trials in December 2019, before announcing the suspension of all trials in January 2020, which had led to a fall of more than 23% of its stock market share.
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In March 2020, Ipsen had resumed trials but only on FOP, research on the treatment of multiple osteochondromas, another rare bone disease, having been stopped due to a lack of “efficacy data».
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