09.10.2012 - German antibody specialist Wilex AG has reached an agreement with the FDA on the further development for its Redectane diagnostic.
According to Wilex, the US regulatory authority accepted the positive vote of an expert committee regarding the clinical usefulness of the test detecting renal tumours. The FDA however demands a second Phase III trial to confirm the diagnostic performance and safety of Redectane. WILEX assumes that an approval can be expected after successful conclusion of this second trial. Originally, the FDA had suggested to run a complex clinical outcomes study to prove the value of Redectane. Dr Paul Bevan, Head of Research and Development, said “eliminating the need for an outcomes-based study – which in our opinion was not a feasible option - will enable us to move forward with our strategy as the regulatory pathway for marketing approval of this innovative imaging agent is now clear. We are delighted with the result.“
Redectane is intended to assist in the detection or exclusion of clear cell RCC during diagnostic workup of an intermediate renal mass. Wilex is already conducting preparatory work for the second trial called REDECT 2 and plans to submit the results to the FDA. German antibody specialist Wilex AG has reached an agreement with the FDA on the further development for its Redectane diagnostic. At the Frankfurt Stock Exchange, Wilex was up more than 5% on Monday.