FDA News

FDA grants orphan drug designation to BPM31510 for pancreatic cancer

The FDA granted orphan drug designation to BPM31510 for the treatment of pancreatic cancer, according to the agent’s manufacturer.

BPM31510 (BERG) targets the dysregulated metabolism in cancer cells by re-engaging the mitochondria to generate energy and shifting cell metabolism.

Researchers are assessing the efficacy of IV BPM31510 alone or in combination with gemcitabine in a phase 2 trial. As part of this trial, researchers are also investigating molecular profiles associated with positive outcomes, which could lead to patient stratification.

“The FDA’s orphan drug designation marks an important milestone for BERG,” Niven R. Narain, president and CEO at BERG, said in a press release. “We look forward to working closely with FDA and other regulatory authorities to advance the clinical development of this therapeutic and map out the most effective match for treatment of pancreatic cancer.”

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 BPM31510 for the treatment of pancreatic cancer, according to the agent’s manufacturer.

BPM31510 (BERG) targets the dysregulated metabolism in cancer cells by re-engaging the mitochondria to generate energy and shifting cell metabolism.

Researchers are assessing the efficacy of IV BPM31510 alone or in combination with gemcitabine in a phase 2 trial. As part of this trial, researchers are also investigating molecular profiles associated with positive outcomes, which could lead to patient stratification.

“The FDA’s orphan drug designation marks an important milestone for BERG,” Niven R. Narain, president and CEO at BERG, said in a press release. “We look forward to working closely with FDA and other regulatory authorities to advance the clinical development of this therapeutic and map out the most effective match for treatment of pancreatic cancer.”

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.