FDA expands Jylamvo approval to include polyarticular juvenile idiopathic arthritis, ALL
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The FDA has expanded the approval of an oral liquid methotrexate solution to include children and adolescents with polyarticular juvenile idiopathic arthritis and acute lymphoblastic leukemia, according to a press release.
The FDA’s decision marks Jylamvo (methotrexate, Shorla Oncology) as the only oral liquid form of methotrexate approved for both adult and pediatric indications currently available on the market, the manufacturer stated.
“This approval follows Jylamvo’s successful use in adult patients and represents a critical step forward in addressing the unmet needs of pediatric care in oncology and autoimmune diseases,” Sharon Cunningham, CEO of Shorla Oncology, said in the release. “We are pleased to offer a convenient, patient-friendly alternative for both adult and pediatric patients in the United States as we continue to develop innovative solutions for those with limited treatment options.”
The FDA first approved Jylamvo in November 2022 for adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis.
According to the company, the drug has an “orange flavor” and includes a dedicated dosing syringe.
“In addition to its palatable formulation, Jylamvo offers key differences over similar drugs, such as room temperature stability for 3 months after opening, which eliminates the need for refrigeration before dispensing and adds convenience for patients,” Rayna Herman, chief commercial officer of Shorla Oncology, said in the release. “We are excited to expand our portfolio of innovative therapies for underserved patient populations.”
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