Agios (AGIO) Gets 18.6% Boost from Aqvesme OK

We recently published 10 Stocks Lighting Up Market Ahead of Christmas. Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) is one of the best performers on Wednesday.

Agios Pharmaceuticals soared by 18.63 percent on Wednesday to close at $29.17 apiece after securing the approval of the Food and Drug Administration (FDA) for anemia treatment, Aqvesme.

In a statement, Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) said that the FDA officially approved Aqvesme to treat anemia in patients with alpha or beta thalassemia. The drug is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

The approval followed the successful phase 3 clinical study for the efficacy of the treatment in 452 enrolled patients. The program met all primary endpoints, demonstrating that Aqvesme can improve hemolytic anemia and a key quality-of-life measure compared to placebo, including significant reductions in transfusion burden and significant improvements in hemoglobin and fatigue.

During the program, however, five patients who received the treatment experienced adverse reactions suggestive of hepatocellular injury (HCI), with two of these patients requiring hospitalization. The side effects occurred within the first six months of exposure, and liver tests improved upon discontinuation of Aqvesme.

To mitigate the risk of HCI, Aqvesme would only be available only through the Aqvesme Risk Evaluation and Mitigation Strategy (REMS) program approved by the FDA, where a liver test is required prior to the first Aqvesme dose, every four weeks thereafter for 24 weeks, and then as clinically indicated.

It also includes education and certification requirements for patients, prescribing physicians, and pharmacists, which are common components of REMS programs.

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Disclosure: None. This article is originally published at Insider Monkey.