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news.The US Food and Drug Administration (FDA) has granted expanded approval to Shorla Oncology’s JYLAMVO (methotrexate) for use in paediatric indications.
JYLAMVO is an orange-flavoured liquid solution sold with a dosing syringe for administration. Credit: Shorla Oncology/Business Wire.
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As per the latest approval, the oral liquid methotrexate drug is intended to treat kids with acute lymphoblastic leukaemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA),
JYLAMVO is available as an orange-flavoured liquid solution, sold with a dosing syringe for administration.
The drug is also said to be stable at room temperature, ranging from 68°F to 77°F, for up to 90 days, without the necessity for cold chain storage before dispensing.
Shorla Oncology CEO Sharon Cunningham said: “This approval follows JYLAMVO’s successful use in adult patients and represents a critical step forward in addressing the unmet needs of paediatric care in oncology and autoimmune diseases.
“We are pleased to offer a convenient, patient-friendly alternative for both adult and paediatric patients in the US as we continue to develop innovative solutions for those with limited treatment options.”
Previously, JYLAMVO received FDA approval in 2022 for use in adults for ALL, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis, and severe psoriasis.
Jylamvo is a product of Therakind, a UK-based pharmaceutical company.
Following its initial approval in the US, Shorla entered into an agreement with Therakind in October last year to acquire the rights to JYLAMVO for the US market.
In December 2023, Shorla, in partnership with EVERSANA, launched JYLAMVO commercially in the US market.
The product also received a European Union Centralised Licence in 2017 and is also authorised for sale in Great Britain, Switzerland, Kuwait, the United Arab Emirates, and Saudi Arabia.
