Incyte Gets FDA Approval For Breakthrough Therapy Status For Its Ruxolitinib

R. Chandrasekaran
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Incyte Corporation (NASDAQ: INCY) revealed Thursday that the Food and Drug Administration has granted Breakthrough Therapy Status for its ruxolitinib for the treatment of patients affected by acute graft-versus-host disease (GVHD). According to the company, there are no approved treatments for patients with acute GVHD currently.

Incyte's Chief Medical Officer, Steven Stein, reacted, "Receiving Breakthrough Therapy Designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to-date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease. We are committed to working closely with the FDA in an effort to bring ruxolitinib to patients with GVHD as soon as possible."

The company indicated that Breakthrough Therapy Status was designed to expedite the development, as well as, review of drugs for serious or life-threatening conditions. The objective is to help ensure people have enough access to them through the regulatory approval as quickly as possible. The criteria for awarding Breakthrough Therapy Designation required preliminary clinical evidence demonstrating that the drug may have clinically considerable improvement over available treatment.

In March current year, Incyte and Lilly agreed to alter their License, Development and Commercialization deal to allow the former to independently develop and commercialize ruxolitinib for GVHD. Similarly, in April, Incyte and Novartis agreed to alter their Collaboration and License Agreement, granting the latter the rights to research, develop and commercialize ruxolitinib for GVHD outside the U.S.

On Wednesday, the stock edged higher by 1.16 percent.

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