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FDA Approves Celgene & Agios Oral Treatment For Leukemia Patients

By Carie P. cpaddayuman@gmail.com | Aug 02, 2017 08:55 AM EDT

The U.S. Food and Drug Administration or the FDA just approved last Tuesday the oral treatment for Acute Myeloid Leukemia or AML patients from Celgene Corp and Agios Pharmaceuticals Inc. It was reported further that the drug is called Idhifa which will be offered on a monthly list price of $24, 872.

Celgene was the one which confirmed this update in an email and noted too that the median time on treatment for AML patients was 4.3 months in the trial. After successfully achieving this, the FDA approved the said oral treatment.

It was also reported on Reuters that patients need not worry about how they can actually afford the said oral treatment for leukemia. Their ability to pay this will be based on their healthcare insurance plans and the length of the treatment needed.

Acute Myeloid Leukemia is a type of cancer in the blood that originates in the bone marrow and develops quickly. As it progresses, there I an abnormal increase in the white blood cells and this type of cancer is often diagnosed in older people while this is rare for people below age 45.

However, Celgene and Agios also mentioned that before the administration of the drug, there should be an approval for a refractory AML patients with an IDH2 mutation first. Apart from this, the administration should also be used with a diagnostic test created by Abbott Laboratories which helps to locate the mutation.

Even if the said oral treatment was not really a big leap for Celgene, it was considered as the first approval for a partnered product with another pharmaceutical company. Besides, the product also targeted an area of clear high unmet need.

Recently, before Celgene and Agios, another AML drug from Novartis AG was also approved which has a list price of $7, 495 for a 14-day treatment duration and $14,990 for a 28-day duration. But the difference is that this treatment is intended for newly diagnosed patients with AML which also carries a genetic mutation called FLT3.

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