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18 Mar 2024
Admin
News Article

Keros Therapeutics’ KER-050 Gets Fast Track Designation

US FDA grants fast track designation to Keros Therapeutics’ KER-050 in lower-risk myelodysplastic syndromes

Overview

Keros Therapeutics, Inc. (Keros), a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for KER-050 (elritercept) for the treatment of anaemia in adult patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS).

Words from CEO on the News

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 S. Seehra, Ph.D., president and chief executive officer. “We look forward to working closely with the FDA as we engage on the design of a phase 3 clinical trial evaluating KER-050 in lower-risk MDS in the first half of this year.

About Fast Track

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.
Programmes 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.

About KER-050

Keros’ lead product candidate, KER-050, is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ß receptor known as activin receptor type IIA that is fused to the portion of the human antibody known as the Fc domain.
KER-050 is being developed for the treatment of low blood cell counts, or cytopenias, including anaemia and thrombocytopenia, in patients with MDS and in patients with myelofibrosis.

About Keros Therapeutics

Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins.

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