The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead’s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized for use across all stages of liver disease.
Safety and Pharmacokinetics Review
The CHMP’s endorsement follows a review of safety and pharmacokinetics data from a Phase I study. The data suggests that no dose adjustment or liver function testing is necessary before or during treatment with Veklury, indicating its potential safety and efficacy in patients with hepatic impairment.
Implications for COVID-19 Treatment
If approved, Veklury would provide a significant therapeutic option for COVID-19 patients with liver disease, who often face limited treatment options due to the potential for drug interactions and exacerbation of liver conditions. This endorsement by the CHMP highlights the importance of broadening access to effective COVID-19 treatments for all patient populations, including those with comorbidities.-Fineline Info & Tech
