AMT's Marketing Authorisation Application for Glybera(R) on Schedule
The company is confident that Glybera(R), a gene therapy product for lipoprotein lipase deficiency (LPLD), remains on track for a regulatory decision by mid-2011.
AMT has had two meetings with the Committee for Advanced Therapy Medicinal Products (CAT) at the EMA for clarification about the Day 120 questions. These meetings have enabled AMT to finalise its strategy for responding to these questions in a timely and effective manner.
The outcome of the meetings suggests that AMT will not be required to conduct more clinical trials with additional new patients to be treated at this time. The responses to the questions will be based in part on additional data and analyses from patients previously treated with Glybera(R). This will include new data available from the last clinical trial (CT-AMT-011-02) and its one year extension.
