Singapore drug-development firm receives "orphan" approval from US
Singapore - The drug-development firm S*Bio has been granted "orphan" approval from the US Food and Drug Administration (FDA) for a product aimed a treating a rare blood disease, the Singapore company said Wednesday.
The designation is awarded by the FDA for promising therapies to treat diseases affecting fewer than 200,000 people in the United States.
The drug, code-named SB1518, is meant to treat myeloproliferative disorders. Characterized by a proliferation of certain blood cells, the disorders can lead to cardiovascular disease and leukaemia.
"Some of the benefits include a tax credit on cost of clinical trials performed in the US," The Business Times quoted chief executive officer Jan-Anders Karlsson as saying. "The compound will also be eligible for fast-track procedure by the FDA with a reduction in the amount of registration fees."
The compound "has potential also for other disease areas which we will explore once we are starting to dose patients," Karlsson said.
It takes about five to eight years from the start of clinical trials for a drug to reach the market. (dpa)