AB Science receives Orphan Drug Designation from the FDA for AB8939

AML (acute myeloid leukemia), a severe, life-threating disease that is one of the most common causes of cancer-related death. Common treatment options for this condition includes stem-cell transplants, chemotherapy and other drug therapy. However, with a massive number of patients experiencing unsatisfactory prognosis, several pharmaceutical firms are working to develop more effective treatment and therapy options.

AB Science SA is one such firm that has made promising development in this field. Recently, the company announced that it has obtained the Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its innovative compound, AB8939, in treating AML.

The Office of Orphan Drug Products Development, a division of FDA, evaluates requests for Orphan Drug status to augment advancements in medicines for patient demographics that are underserved or for rare disorders which impact less than 200,000 people across the U.S. 

Reportedly, the Orphan Drug status would grant AB Science a marketing exclusivity of 7-year in the United States after the FDA approves it. Moreover, this status would allow the firm to register for research grant funding for both Phase 1 as well as Phase 2 clinical studies and also receive tax credits on certain research expenses. 

It would also offer a potentially faster regulatory process to the candidate if it receives a breakthrough therapy designation and/or a priority review along with a waiver from FDA's prescription drug user fee.

As per reports, the review of AB8939 was supported by preclinical results that showed the potential to enhance the treatment of AML. Based on the outcomes, AB8939 might therefore provide a significant therapeutic benefit for AML treatment, especially in relapsed/refractory AML patients that have had the poorest prognosis.

According to experts, amidst the entire population of AML patients, nearly 50% of them would not have stem-cell transplantation and are prone to relapse. Thus, the projected patient population for AB8938 is expected to be around 80,000 people in the U.S. and Europe combined.
 

Source Credit: https://finance.yahoo.com/news/ab-science-announces-ab8939-receives-072647504.html