Seven new medicines backed for approval by EMA/CHMP at November meeting

10 November 2017

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new drugs for approval, including two orphan medicines and one biosimilar, at its November 2017 meeting.

The CHMP opinions will now be sent to the European Commission for the adoption of a decision on a European Union-wide marketing authorization, which is usually announced with two or three months.

The CHMP recommended granting a marketing authorization for Jorveza (budesonide), from German drugmaker Dr Falk Pharma GmbH, to treat eosinophilic esophagitis, a rare inflammatory condition of the oesophagus. There is currently no authorized medicine available to treat the condition and EMA’s CHMP reviewed the application for Jorveza under its accelerated assessment procedure, which is reserved for medicines of major public health interest.

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