FDA News

FDA grants orphan drug designation to CG’806 for acute myeloid leukemia

The FDA granted orphan drug designation to CG’806 for the treatment of acute myeloid leukemia, according to the agent’s manufacturer.

CG’806 (Aptose Biosciences) — an oral, first-in-class pan-FLT3/pan-BTK inhibitor — targets oncogenic pathways that drive the proliferation of AML cells.

“We are pleased that the FDA has recognized the unique potential of CG’806 to address AML and has assigned CG’806 the status of orphan drug designation,” William G. Rice, PhD, chairman, president and CEO of Aptose Biosciences, said in a company-issued press release. “Results from nonclinical studies that we and our research collaborators have generated are promising and give reason for our eagerness to begin clinical trials in both AML and B-cell malignancies in 2018.”

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.

The FDA granted orphan drug designation to CG’806 for the treatment of acute myeloid leukemia, according to the agent’s manufacturer.

CG’806 (Aptose Biosciences) — an oral, first-in-class pan-FLT3/pan-BTK inhibitor — targets oncogenic pathways that drive the proliferation of AML cells.

“We are pleased that the FDA has recognized the unique potential of CG’806 to address AML and has assigned CG’806 the status of orphan drug designation,” William G. Rice, PhD, chairman, president and CEO of Aptose Biosciences, said in a company-issued press release. “Results from nonclinical studies that we and our research collaborators have generated are promising and give reason for our eagerness to begin clinical trials in both AML and B-cell malignancies in 2018.”

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.