Gilead's COVID drug Veklury, cancer therapy Yescarta get EMA panel backing for expanded use
Waldemarus

A committee of the European Medicines Agency (EMA) recommended the approval of expanded use of Gilead Sciences' (NASDAQ:GILD) Veklury (remdesivir) to treat pediatric patients who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.
The EMA's Committee for Medicinal Products for Human Use (CHMP) also issued positive opinion for approval of Veklury's use in children 4 weeks of age and older with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).
The CHMP's decision was backed by data from an ongoing phase 2/3 trial called CARAVAN.
In addition, CHMP also recommended the expanded approval of Yescarta (axicabtagene ciloleucel) for adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) which relapses within 12 months from completion of, or is refractory, to first-line chemoimmunotherapy.
The company said that if approved, Yescarta will be the first Chimeric Antigen Receptor (CAR) T-cell therapy approved for patients in Europe who do not respond to first-line therapy.
The CHMP positive opinion was based on results from a phase 3 trial called ZUMA-7.
The European Commission, which generally follows the opinion of the CHMP, will now decide on the approval of the two drugs.
GILD -0.77% to $64.50 premarket Sept. 16