Achieved through a Type II variation, the production site approval will allow Pharming to supply the European market with drug substance from Sanofi Chimie.
The approval will also enable necessary improvements in Ruconest’s competitiveness and will allow Pharming to meet the global demands in future with a supply chain long term agreement for the treatment of hereditary angioedema (HAE) and follow-up indications.
Pharming COO Bruno Giannetti said that the approval from the EMA to manufacture Ruconest at the Sanofi’s France site is an important development for the company.
"Importantly, this approval significantly enhances Ruconest’s competitive profile, as it enables us to ramp-up manufacturing of Ruconest and optimizing the cost of goods for the product," Giannetti added.
Ruconest is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with (HAE) in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum.