Ipsen hit another stumbling block in its bid for an FOP approval as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
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Ipsen‘s fibrodysplasia ossificans progressiva (FOP) odyssey continues as the FDA‘s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
The FDA has requested additional information on clinical trial data that “does not relate to the safety profile of palovarotene,” Ipsen stated Tuesday. The meeting was previously scheduled for Oct. 31, and the new date has not yet been confirmed.
In the press release, Ipsen stated it is currently working to fulfill the agency’s request for new information.
“We will work expediently with the FDA as we remain committed to bringing innovative treatment options to the fibrodysplasia ossificans progressiva community,” the company stated.
Ipsen submitted the NDA for palovarotene for the prevention of heterotopic ossification in females eight years and older and males 10 years and older with FOP.
Palovarotene is an oral investigational, selective retinoic-acid receptor gamma (RARγ) agonist. FOP is an ultra-rare genetic disorder that causes heterotopic ossification (HO). HO occurs when bone forms in places it shouldn’t, such as outside of the skeleton.
A Rocky Road for Ipsen
As BioSpace previously reported, the FDA originally accepted Ipsen’s NDA for priority review on May 28, 2021. Three months later, Ipsen withdrew the application, stating in a press release that after talks with the FDA, “it was recognized that additional analyses and evaluation of data collected from [the] Phase III MOVE and FOP program would be required to progress and complete the review process.”
Ipsen stated it would not be able to provide this additional information within the time frame of the review cycle, leading to the withdrawal of the application.
It then resubmitted the application, and on June 29, announced the FDA had again accepted the NDA for priority review. In the June announcement, the company listed a target action date of Dec. 29 for the application.
Ipsen originally acquired Palovarotene through the acquisition of Clementia Pharmaceuticals in April 2019.
The drug was approved in Canada in January. Health Canada was the first regulatory authority to approve Sohonos (palovarotene capsules) to reduce the formation of HO in adults and children aged 8 years and above for females and 10 years and above for males with FOP.
Ipsen stated it also filed a Marketing Authorization Application for palovarotene in the E.U. in 2021. It then submitted responses to questions raised by the European Medicines Agency in June 2022.
