Drugs

FDA OKs Mesoblast’s Ryoncil Cell Therapy

FDA has approved Mesoblast’s Ryoncil (remestemcel-L-rknd), an allogenic bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated to treat steroid-refractory acute graft-versus-host disease in pediatric patients aged two months and older. An agency statement says Ryoncil is the first FDA-approved MSC therapy.

The safety and effectiveness of Ryoncil were evaluated in 54 pediatric patients. Its effectiveness was based primarily on the rate and duration of response to treatment 28 days after initiating Ryoncil, the agency says. Some 16 study participants (30%) had a complete response to treatment 28 days after receiving Ryoncil, while 22 (41%) had a partial response.

The most common adverse reactions in study participants who received Ryoncil were infections, fever, hemorrhage, edema, abdominal pain, and hypertension.

The application received orphan drug, fast track, and priority review designations.

FDA OKs Mesoblast’s Ryoncil Cell Therapy

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