Pharming Group has received confirmation of validation from EMEA of its Marketing Authorization Application (MAA) for Rhucin. Consequently the formal scientific evaluation procedure of the European Medicines Agency (EMEA) has commenced.
The company said that Pharming submitted the MAA for Rhucin to EMEA earlier this month. The EMEA notified the company that it has completed the validation of the dossier. As result of this, the Centralised Procedure for scientific evaluation of the MAA by the Committee for Medicinal Products for Human Use (CHMP) has started.
The company should submit its responses to these questions within 3 months, after which the ‘clock’ would restart and the procedure would be continued. Pharming may expect the adoption of the final CHMP opinion within a total of 210 days review time (excluding any clock-stops).
Rhucin (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming’s proprietary technology where the human protein is expressed in milk of transgenic rabbits.
Pharming is engaged in the development of products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products.