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news.Amsterdam Molecular Therapeutics has announced that the European Commission has delayed its decision on granting marketing authorization for Glybera (alipogene tiparvovec) as recommended by the Committee for Human Medicinal Products (CHMP).
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AMT has developed Glybera as a treatment for patients with the genetic disorder lipoprotein lipase deficiency (LPLD).
On 23 October 2011, AMT received a non-approvable opinion from the CHMP (following a re-examination of the marketing approval dossier originally rejected in June 2011) despite a recommendation to approve Glybera by the Committee For Advanced Therapies (CAT).
The CAT is an expert body implemented by the European Commission to prepare and advise the CHMP on decisions regarding advanced therapeutics, in particular gene and cell therapies.