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The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.
The European Medicines Agency (EMA) announced on Oct. 14, 2016 that the agency’s Committee for Medicinal Products for Human Use (CHMP) was recommending conditional marketing authorization for Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cholangitis, a rare and life-threatening disease that causes the gradual destruction of the small bile ducts in the liver. According to EMA, Ocaliva may be used in combination with ursodeoxycholic acid (UDCA) in patients who have not responded adequately to UDCA, or on its own in adults who are unable to tolerate treatment with UDCA.
Conditional approval, which allows EMA to recommend a drug for marketing authorization before the availability of confirmatory clinical trial data, may be given if the benefits outweigh the risks inherent in the lack of comprehensive data. A Phase III study, which included 216 participants, showed that after 12 months “the proportion of patients achieving reductions in levels of their alkaline phosphatase (an indicator of disease progression) was higher in patients treated with Ocaliva (about 47% compared to 10% in the placebo group).” Ocaliva’s applicant must provide results from two studies as part of the conditional marketing authorization, and CHMP will review the benefits and risks of Ocaliva annually, until all data are obtained, to determine whether the conditional marketing authorization can be maintained.