FDA denies Ocaliva full approval in primary biliary cholangitis; safety data still in play
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Key takeaways:
- In line with an earlier panel decision, FDA denied full approval to Ocaliva for primary biliary cholangitis.
- FDA continues to “consider safety data” for the drug.
The FDA issued a complete response letter to Intercept Pharmaceuticals indicating it cannot grant full approval to the company’s supplemental new drug application for Ocaliva as a treatment for primary biliary cholangitis.
As Healio previously reported in September, the FDA Gastrointestinal Drug Advisory Committee voted 13 to 1 with no abstentions that the benefits of Ocaliva (obeticholic acid, Intercept Pharmaceuticals) on clinical outcomes in patients with PBC without cirrhosis or compensated cirrhosis with portal hypertension could not be verified with available data.
In its letter, the FDA noted that it was unable to approve the company’s drug application in its current form. However, the agency stated that it was “continuing to consider safety data” from Intercept’s postmarketing requirement confirmatory trial, 747-302, indicating a potential benefit not found in other available therapies.
“We believe in the totality of evidence supporting Ocaliva and intend to work closely with the FDA on next steps,” Vivek Devaraj, the U.S. president and chairman at Intercept, said in the press release. “We remain committed to patients living with PBC who have limited treatment options.”
Under its accelerated approval status, Ocaliva will remain a secondary option for patients with PBC who fail to adequately respond to first-line ursodeoxycholic acid or cannot tolerate its use.
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