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Celgene Corporation (NASDAQ:CELG) Gets FDA Fast Track Designation For Two Trials

Celgene Corporation (NASDAQ:CELG) collaborations have been benefiting the company, and the U.S. Food and Drug Administration has given a green signal to two of its projects. Reportedly, the drug deals with Agios Pharmaceuticals Inc (NASDAQ:AGIO) and Acceleron Pharma Inc (NASDAQ:XLRN) are set to reach their final trials after the regulatory nod. The FDA has added both the treatments in its fast-track program to help speed up the process.

FDA gave the fast track designation to Agios Pharmaceuticals’ AG-120 that is working on trials for treating acute myelogenous leukemia (AML), a marrow cancer type. Chief Medical Officer of Agios Chris Bowden said that they were happy that AG-120 and AG-221 got the FDA nod.

Breakthrough Drugs

He said that the drugs were going to be a breakthrough in treating mutations caused by AML, and these new therapies would be helpful to a larger population. The AG-120 is aimed at cellular metabolism that is going to help make the cancer die through launching a cell attack. Celgene plans to add another $120 million in the project in the upcoming period for initiating further trials and development of the drug.

Acceleron Pharma got the fast track designation for luspatercept that is being tested for treating a rare blood disorder beta-thalassemia that causes iron overload and organ breakdown. Both the companies are going to enter the Phase 3 in 2016, and the results of the ongoing study would be presented in June 2015. Celgene has partnered with the two companies to help in the development of the drugs, and the royalties would be divided once the medicine starts selling.

Faster Processing

The FDA move has come as a boost to help these companies in making drugs that will help in curing beta-thalassemia and AML, as not many options are available in this domain. The fast track tag will help in getting faster clearances for the trials of the two drugs, and the entire process may not take more than ten months.

Celgene has invested over $1 billion in partnerships in April 2015 and is committed to expanding its reach by following a successful strategy that is helping the company for sure.