Background to Regulatory Process
In 2009, AMT filed Glybera for European marketing authorization "under exceptional circumstances". In Europe, this submission process is intended to allow drugs for extremely rare diseases to be approved, realizing that the clinical development package will never contain all the information that would be required for a more common condition.
The dossier was examined by the Committee for Advanced Therapies (CAT) and the CHMP, and in June 2011 both voted against approval of Glybera. AMT appealed the decision based on its interactions with representatives from the CHMP and two new CHMP Rapporteurs were appointed to lead the review process. During the appeal, both rapporteurs, an external scientific advisory group (SAG) consisting of European experts in the areas of gene therapy, lipid metabolism and pancreatitis, was appointed to review and analyze the data and to advise the EMA on its conclusions. The SAG concluded that Glybera should be approved under exceptional circumstances. Subsequently, the CAT performed its own analysis and also voted by a large majority in favor of Glybera marketing authorization. The advice from the SAG, the CAT and both the CHMP Rapporteurs, was provided to the CHMP. However, the CHMP did not change its previous opinion and again voted with the narrowest majority against Glybera marketing authorization. The Company has not yet been informed of the reasons for the CHMP decision.
Following a careful review of operations and resources needed for development of its remaining pipeline products, AMT management will work in close consultation with the works council to assess the impact of the review on the company's workforce. Management and board believe that for AMT to remain a viable business it needs to reduce the headcount by 50% to 45 full-time employees.
The measures announced to
|SOURCE Amsterdam Molecular Therapeutics (AMT) B.V|
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