Pharming Group N.V. has received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for the Ruconest.
With the addition of this new facility, Pharming will significantly increase the production capacity of Ruconest as it becomes fully operational over the coming year. Pharming is now also able to release the product that was manufactured at the facility during the approval process for commercialisation in the EU. As previously announced, Pharming had identified a potential risk of short-term pressure on the supply of Ruconest for the European market due to increasing demand for the product. With the approval of this new facility, the Company believes the risk to supply is now greatly reduced.
The new facility’s post-approval supplement (PAS) for the distribution of Ruconest in the US is still under review by the Food and Drug Administration (FDA). Approval of the new facility for distribution in the US is expected in H1 2020.
Sijmen de Vries, CEO of Pharming, says:
“As we continue to see increasing demand for Ruconest in the treatment of HAE, we are pleased to announce the approval of our new facility, which will enable us to significantly increase production capacity for supply to patients in the EU. In addition, as a result of our recent re-acquisition of Ruconest’s European distribution rights from Sobi, this capacity expansion will allow us to reach an even greater number of EU patients.”