FDA Accepts New Drug Application And Grants Priority Review For Enasidenib In Relapsed Or Refractory AML With An IDH2 Mutation

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Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals Inc (NASDAQ:AGIO) both of which are biotech stocks have announced that Celgene’s application for for enasidenib (AG-221/CC-90007) has been accepted by the Food and Drug Administration (FDA). Enasidenib is used in the treatment of refractory acute myeloid leukemia (AML). The New Drug Application (NDA) was given Priority Review and collected by Celgene in late December 2016.

President, Hematology/Oncology at Celgene Michael Pehl says the application was accelerated having been submitted only three years after it was used on the first patient. He attributed the accelerated application to the need to fill the unmet demand among people suffering from refractory AML.

Enasidenib is an oral first-in-class and mutant IDH2 inhibitor. The submission of the application was based on results from AG221-C-001, a phase I/II trial of enasidenib in patients with severe hematologic malignancies.

Agios M.D., chief executive officer David Schenkein says the company will be working with Celgene and FDA to develop a first-in-class treatment for AML with an IDH2 mutation.

Abbott has applied for a Premarket Approval (PMA) for approval by FDA for its Abbott m2000 RealTime System. The system is a polymerase chain reaction (PCR) molecular diagnostics process.

Celgene is also analyzing enasidenib in comparison to conventional therapy in previous patients with an IDH2 mutation together with relapsed or refractory AML.  Enasidenib is yet to be approved for use in the U.S but currently used as an investigational drug.

Acute Myelogenous Leukemia is a blood and born cancer associated with rapid disease development. It is the most prevalent type of leukemia in adults. The disease causes incomplete cell divisions which then reproduce rapidly in the marrow instead of maturing into normal cells. Incidences of AML increase with increase in age and the optimal age is 66.

With headquarters in Summit, New Jersey, Celgene is one of the top biotech stocks biopharmaceutical company specializing in discovering, developing, marketing and commercialization of highly researched and innovative therapies for cancer treatment as well as treatment of inflammatory diseases.


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