AB Science receives Orphan Drug Designation from the FDA for AB8939
Category: #health  By Mateen Dalal  Date: 2019-11-08
  • share
  • Twitter
  • Facebook
  • LinkedIn

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

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

Gennova begins enrollment for Phase 1/2 trials of mRNA COVID vaccine
Gennova begins enrollment for Phase 1/2 trials of mRNA COVID vaccine
By Mateen Dalal

India's first mRNA-based COVID-19 vaccine, HGCO19, formulated by Pune-based biotech firm, Gennova Biopharmaceuticals is about to enter its Phase 1/2 clinical trials with the enrollment of candidates, said the Department of Biotechnology (DBT). R...

Mashcor launches new independent search engine for the Afrotech sector
Mashcor launches new independent search engine for the Afrotech sector
By Mateen Dalal

Mashcor, a leading South African digital agency, has reportedly announced the launch of Africa’s first indigenous search engine. The new search engine has been specifically designed to connect the region’s rapidly expanding tech sector to...

Canada and Germany ink new energy partnership with emphasis on hydrogen
Canada and Germany ink new energy partnership with emphasis on hydrogen
By Mateen Dalal

The government of Canada has inked a new, comprehensive energy partnership deal with the government of Germany to set up a formal collaboration across a wide array of shared energy priorities, including hydrogen and LNG. According to reports, this c...