Boston, MA 06/10/2014 (wallstreetpr) – Pharmacyclics, Inc. (NASDAQ:PCYC) announced that the U.S. Food and Drug Administration has agreed to file its supplemental New Drug Application in support of the review of its drug IMBRUVICA for the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma for complete approval. The supplemental NDA is useful in the therapy of patients who have received at least one treatment previously.
FDA’s Approval
Pharmacyclics, Inc. (NASDAQ:PCYC) had submitted the supplemental NDA to the FDA on the basis of data it had obtained from the multi-center, randomized, open label last phase RESONATE™ trial, PCYC-1112-CA, which was a strict comparison of IMBRUVICA™ and ofatumumab. The study involved 391 patients diagnosed with CLL or SLL and all of whom had received at least one therapy previously. The FDA seeks to finalize reviewing the application as per the target date laid down by the Prescription Drug User Fee Act which is Oct 7, 2014.
IMBRUVICA, which is the first drug to be filed for approval by the FDA via the novel Breakthrough Therapy Designation conduit, was approved for prior treated MCL in Nov, 2013. It was also approved by the FDA for prior treated CLL, which is the commonest form of leukemia found in adults in the Western countries, in February this year. The pathway through which the drug was filed with the FDa for approval ensures Pharmacyclics, Inc. (NASDAQ:PCYC) the quickest delivery of the medicine to the patients.
Compelling Data
The company’s Global Regulatory Affairs’ Senior Vice President, Dr. Urte Gayko, said that the company is expecting to continue work with the FDA after they finish the review procedure. He believes that the data the company has submitted is compelling to provide it the desired outcome of the review.
Soon after Pharmacyclics, Inc. (NASDAQ:PCYC) announced the news today, of the FDA approving the company’s supplemental NDA filing, its shares increased 3.8% and surged up to as much as 97.07.
