The U.S. FDA has declined to approve palovarotene developed by French pharma company Ipsen S.A. ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) to reduce abnormal bone formation in people living with ultra-rare disease fibrodysplasia ossificans progressiva (FOP).
The FDA has communicated its decision to Ipsen ( OTCPK:IPSEY ), issuing a so-called Complete Response Letter (CRL) which the company said relates to the agency’s previous request for additional info on palovarotene clinical trial data.
That request sent in October 2022 did not cite the need for additional data beyond existing studies, Ipsen ( OTCPK:IPSEY ) said, adding that the company intends to respond to the CRL in Q1 2023 expecting a six-month FDA review cycle.
“Currently, people living with FOP in the U.S. have no approved treatment option to slow the progression of the disease and this remains our reason for being steadfast in our pursuit of bringing this potential treatment option for FOP,” Ipsen’s ( OTCPK:IPSEY ) Head of R&D Howard Mayer said.
The authorities in the UAE and Canada have already cleared palovarotene under the brand name Sohonos.
In August 2021, Ipsen ( OTCPK:IPSEY ) pulled the New Drug Application (NDA) for palovarotene in the U.S. with plans to resubmit the marketing application after completing additional data analyses.
For further details see:
Ipsen says FDA rejected treatment for rare bone disorder