Ipsen Withdraws NDA for RARγ Agonist Palovarotene in the U.S. Following FDA Discussions
Ipsen
Biopharmaceutical Manufacturer
FDA
U.S. Food and Drug Administration
On August 13, foreign media reported that Ipsen announced, following recent discussions with the U.S. Food and Drug Administration (FDA), the withdrawal ofRARγ AgonistNew Drug Application (NDA) for palovarotene.
Ipsen and the FDA have agreed that it is not possible to complete the Phase III MOVE (NCT03312634) clinical trial for this drug within the current NDA review cycle. Therefore, following recent discussions with the FDA, Ipsen plans to resubmit the New Drug Application to the FDA after completing additional data analysis.
It is reported that in May this year, the FDA accepted the New Drug Application (NDA) for palovarotene and granted it Priority Review. The drug is indicated for the treatment of fibrodysplasia ossificans progressiva (FOP, also known as "Stone Man Syndrome").
As a selective RARγ agonist, palovarotene inhibits BMP signaling, thereby preventing heterotopic ossification and delaying the progression of this devastating disease. The product was acquired by Ipsen through its acquisition of Clementia Pharmaceuticals in April 2019.
*Disclaimer: This article was written by a contributing author to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.