Mesoblast submits BLA to get Ryoncil™ FDA-approved for treating SRaGVHD
Category: #health  By Pankaj Singh  Date: 2020-02-04
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Mesoblast submits BLA to get Ryoncil™ FDA-approved for treating SRaGVHD

Mesoblast Limited has recently announced the submission of the completed BLA (Biologics License Application) to the U.S. FDA (Food and Drug Administration) for Ryoncil™. Mesoblast is an Australian regenerative medicine company that develops cellular medicines for inflammatory diseases. Ryoncil™ (remestemcel-L), an allogeneic cell therapy, is used for the treatment of children with SR-aGVHD (steroid-refractory acute graft versus host disease).

The company filed the final module of this rolling BLA submission with the FDA on 31st January 2020. The application covers manufacturing and quality control of the product. The company has requested FDA to expedite the process by conducting a Priority Review of this application under the existing Fast Track designation of the product candidate for SR-aGVHD. The company is expected to start marketing Ryoncil™ in the United States in 2020, once approved.

According to the statement made by Dr. Silviu Itescu, Chief Executive of Mesoblast, the recent BLA submission marks a new business accomplishment for the company. Additionally, the company is planning to continue working with the FDA for marketing Ryoncil™, in order to better serve children who suffer from this potentially fatal illness, with its innovative biologic application therapy.

Acute graft-versus-host disease (GVHD) is estimated to occur among nearly 50% of patients who have undergone allogeneic BMT (bone marrow transplant). Nearly 30,000 patients receive allogeneic BMT each year, primarily for the treatment of blood cancers, with numbers rising.

The mortality rate for patients suffering from severe form of GVHD is more than 90%, despite compliance with optimal institutional standard of care. In the United States, there are no FDA-approved treatments for SR-aGVHD infected children under 12 years of age.

Three distinct studies have been conducted with 309 children with SR-aGVHD, involving the use of Ryoncil™ as a treatment solution. In addition, the product was used among 241 SR-aGVHD infected children (with 80% Grade C/D) as salvage therapy in an expanded access program. It was also adopted among 55 children with SR-aGVHD, of which 89% had Grade C/D, as first-line therapy in open-label Phase 3 trial of Mesoblast.

Source credit: http://investorsmedia.mesoblast.com/static-files/17c0369d-3517-4b0c-90bd-c07af59650bf



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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