Ipsen Biopharmaceuticals, Inc.
NEWS
After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
The first half of this year saw milestone approvals for rare disease therapies, and the FDA has several more such decisions on its calendar in the second half of 2023.
The companies Friday reported positive late-stage results for elafibranor as a second-line treatment for primary biliary cholangitis, a rare liver disease.
An FDA advisory committee voted Wednesday that Ipsen’s fibrodysplasia ossificans progressive candidate palovarotene was effective and the benefits of the drug outweighed its risks.
The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.
Phase III data showed Ipsen’s Onivyde boosted overall survival in metastatic pancreatic ductal adenocarcinoma.
Ipsen bolsters rare disease portfolio with acquisition of liver disease specialist Albireo.
Ipsen will seek a new approval for Onivyde as a treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) after posting positive Phase III progression survival data.
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