November 5 ,2013 | By Márcio Barra
The European Medicines Agency has launched yesterday, November 4th, a public catalogue containing information on supply shortages of medicines that affect more than one European Union Member state. While the catalogue does not provide a complete overview of all medicine shortages occurring in the EU – most drug shortages are dealt with at a national level by each country National Competent Authority – it provides recommendations to patients and health professionals on how to gain access to the affected product.
The catalogue also includes information on the reason and extent of the shortage and its current status.
Drugs which were identified by EMA as having shortages include Cerezyme (imiglucerase), Fabrazyme (agalsidase beta), Increlex (mecasermin) and Vistide (cidofovir). Ceremyze and Fabrazyme, from Sanofi/Genzyme, are two drugs approved for rare diseases, Gaucher disease and Fabry disease, respectively. Both these drugs are currently facing shortages due to manufacturing issues. Genzyme’s production site for Cerezyme and Fabrazyme in Allston Landing, in the United States of America, shut down in June 2009, because viral contamination (calicivirus of the type Vesivirus 2117) required sanitisation of the bioreactors. According to the EMA, the virus affects the quantity, but not the quality, of the enzymes produced in the bioreactors.
The two other drugs with shortages assessed by the EMA are Ipsen’s Increlex (mecasermin), for the treatment of growth disorder due to severe primary insulin-like growth factor-1 deficiency, and Gilead Sciences’ Vistide (cidofovir), for the treatment of cytomegalovirus infection of the retina. Increlex supply shortages stem from problems at the manufacturing site in the United States in April 2013. As for Vistide, it was due to quality issues observed in one of the batches of the drug.
In Portugal, Increlex was expected to go out of stock in August 2013. As for Vistide, Infarmed started a voluntary recall of several batches of the drug Vistide in December 2011. The supplies of Cerezyme and and Fabrazyme were expected to return to normal in Portugal in April of 2010, but Genzyme announced the continued delay in the supply of Cerezyme and Fabrazyme in April 2010.
The launch of the catalogue is one of the steps of a plan developed by the EMA in 2012 to provide guidance on dealing with drug shortages caused by manufacturing problems. It’s main goal is to provide both short- and medium-term plans to both prevent and manage medicines shortages on a pan-European level.