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FDA Updates: Invokana Warning Lifted, FoundationOne Liquid Biopsy, EUA Expands for Remdesivir


This week's FDA updates include an end to a boxed warning for a type 2 diabetes drug, an expanded emergency use authorization due to COVID-19, and another liquid biopsy.

Box warning ends for SGLT2 inhibitor. After more than three years, FDA on Wednesday lifted a boxed warning for Janssen’s Invokana, the original drug in class called sodium glucose cotransporter 2 (SGLT2) inhibitors. First approved for type 2 diabetes in 2013, Invokana jumped to an early lead against competitors Farxiga (AstraZeneca) and Jardiance (Boehringer-Ingelheim/Eli Lilly), before an amputation signal appeared in its FDA-mandated cardiovascular outcomes trial in 2017. Although the drug later achieved cardiovascular and renal indications, the boxed warning hurt Invokana’s sales relative to its competitors. The signal did not appear in later trials, however. FDA’s action came on the eve of this weekend’s European Society of Cardiology 2020 Congress, where major studies found heart failure benefits for Jardiance and renal benefits for Farxiga.

FoundationOne CDx Launches. OnFriday, Foundation Medicine launched the FoundationOne CDx liquid biopsy following FDA approval for use in all solid tumors. The blood test analyzes more than 300 genes and genomic signatures across all solid tumor types. This the second such approval in a month. Foundation Medicine said in a statement that the approval is a companion diagnostic for 4 FDA-approved targeted therapies, including the PARP inhibitor Rubraca for prostate cancer, and 3 TKI inhibitors for non-small cell lung cancer. It can also report genomic alteration results, blood tumor mutational burden and high microsatellite instability, and single gene alterations, including NTRK fusions.

Expanded scope for remdesivir EUA. Late Friday, FDA announced it would broaden the scope of an existing emergency use authorization for remdesivir (Veklury) to include treatment of all hospitalized adult and pediatric patients with suspected of laboratory confirmed coronavirus disease 2019 (COVID-19), “irrespective of the severity of the disease,” according to a statement. The Gilead Sciences drug received an EUA in May for patients with severe COVID-19, such as those on oxygen therapy or in need of a ventilator. Based on information, the statement says, FDA has determined that the expanded EUA is warranted because “the known and potential benefits of Veklury outweigh the known and potential risks for these uses.” A statement cited “analysis of additional data from 2 randomized, controlled clinical trials that included patients with mild or moderate disease.”

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