FDA Awards Keros Fast Track Designation for Experimental Therapy to Treat MDS

Rare Daily Staff

The U.S. Food and Drug Administration has granted Fast Track designation for Keros Therapeutics’ experimental therapy KER-050 for the treatment of anemia in adult patients with very low-, low-, or intermediate-risk myelodysplastic syndromes.

KER-050 is being developed to treat ineffective hematopoiesis, the process by which blood cells are produced in the bone marrow. When cells properly mature, they leave the bone marrow and enter circulation. Ineffective hematopoiesis—the failure of immature blood cells to properly develop into mature cells—may lead to low levels of circulating red blood cells, low levels of white blood cells, or low levels of platelets. These conditions are known as anemia, neutropenia, and thrombocytopenia.

Keros’ lead product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with MDS and in patients with myelofibrosis.

“Receiving Fast Track designation for KER-050 underscores the need for novel treatment options to address the serious unmet medical needs of people living with lower-risk MDS,” said Jasbir Seehra, president and CEO of Keros Therapeutics.

Fast Track is a process designed by the FDA to facilitate the development and expedite the review of investigational treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the product candidate’s development plan in addition to a rolling submission of the marketing application. Product candidates with Fast Track designation may also be eligible for priority review and accelerated approval.

Photo: Jasbir Seehra, president and CEO of Keros Therapeutics