EMA/CHMP backs approval of five new medicines at October meeting

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new branded medicines for approval at its October 10-13 meeting.

The CHMP recommended granting a conditional marketing authorization in the European Union to US biopharma firm Intercept Pharma’s (Nasdaq: ICPT) orphan drug Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cholangitis (also known as primary biliary cirrhosis). Ocaliva is to be used in combination with another medicine, 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 is one of EMA’s main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs. It allows the Agency to recommend a medicine for marketing authorization before the availability of confirmatory clinical trial data, if the benefits of making this medicine available to patients immediately outweigh the risks inherent in the lack of comprehensive data.