Pharming receives US approval for expanded Ruconest production
Pharming was given approval from the US Food and Drug Administration (FDA), after the company applied for prior approval supplement to produce starting material for Ruconest (conestat alfa) for the US market.
The FDA’s approval arrives shortly after the company received the same decision by the European Medicines Agency (EMA) at the end of January.
As a result, Pharming will be able to release starting materials for its product to both of its major markets, with chief executive, Sijmen de Vries, noting that with the newly approved facility, it has capacity to meet current demand for the product.
Ruconest is a recombinant human C1 esterase inhibitor that is approved for the treatment of acute hereditary angioedema attacks in patients. It has been approved for use in Europe, the US, Israel and South Korea.
Pharming recently reacquired the rights to the product for a sum of €7.5m ($8.5m) from Sobi, after a similar decision in 2016 with Valeant Pharmaceuticals for US rights.
The company is also working to expand the number of indications for the treatment, though De Vries has previously noted that it may need to alter the manner in which it produces the products to cope with any additional patient demand.
Ruconest is currently produced through a rabbit platform, which produces milk containing the recombinant protein, but this may need to be altered as it would be ‘unpractical’ to manufacture the product at the required scales.