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news.The US Food and Drug Administration (FDA) has accepted the Phase III trial design for evaluating recombinant human C1 inhibitor (Rhucin) under special protocol assessment (SPA) agreement.
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Rhucin is under investigation as a treatment for acute attacks of angioedema for patients suffering from hereditary angioedema (HAE).
The companies have received the FDA acceptance for Pharming’s proposed clinical endpoints, statistical analyzes and the trial design.
The changes to the study design include, a modification to the way the primary endpoint will be assessed and an increase in the number of patients from 50 to approximately 75.
The protocol will also be changed to allow the introduction of open-label doses of Rhucin as a rescue medication.
Earlier, Pharming has got license from Santarus to commercialize Rhucin in North America.
Pharming chief medical officer Rienk Pijpstra said over the past months they have continued to open additional investigational sites and to screen patients for eligibility who can now be randomized into the amended trial.