Wednesday, August 28, 2013

FDA accepts IMBRUVICA sNDA for review of Pharmacyclics

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FDA accepts IMBRUVICA sNDA for review of Pharmacyclics -

Pharmacyclics, Inc. (Nasdaq: PCYC) announced today that the US Food and Drug Administration (FDA) accepted filing the supplementary New Drug Application (sNDA) to support the review of IMBRUVICA (Ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who received at least one prior treatment full approval. The sNDA was submitted to the FDA based on data from the randomized, multicenter, RESONATE ™ III trial phase opened PCYC-1112-CA, a comparison head-to-head against IMBRUVICA ™ ofatumumab in 391 patients CLL or SLL who had received at least prior therapy. The target date as defined by the Prescription Drug User Fee Act by which the FDA intends to finalize its consideration of the application (date PDUFA) is October 7, 2014.

"We are pleased to receiving the acceptance of our sNDA filing by the FDA. We believe that all the data that we presented is compelling, "said Dr. Urte Gayko, Senior Vice President of global regulatory Affairs, Pharmacyclics. "We look forward to continue working with the FDA as they complete their review of this application."


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