Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations
Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP. Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn an application for another.
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This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
CTI BioPharma has had a bumpy ride with pacrotinib, its investigational treatment for patients with myelofibrosis who have thrombocytopenia. But it has persevered and should learn this week whether the European Medicines Agency will recommend that the product be approved for the sale across the EU. Pacritinib, J&J's apalutamide, and AEterna Zentaris's macimorelin are among a handful of products reaching the end of the approval process.