The BBC has reported that the application of GTC Biotherapeutics to license Atryn, produced in the milk of transgenic goats, has been refused. The European Medicines Agency (EMEA) has called for more evidence of the benefits of the drug, in order to outweigh the perceived risks associated with the licensing of the medicine. In particular, the EMEA said evidence showing that there was no development of an unfavourable immune response to the drug had not been adequate. The EMEA refusal is noted in a recent press release and its recommendations set out the reasons for refusal in more detail. The BBC report describes this as a major setback for the promises of cheaper living drugs, heralded in the late 1990s but yet to be delivered.
No comments:
Post a Comment