Country: BRAZIL | Region: SOUTH AMERICA | Type: Regulation | Keywords: #anvisa #compassionateuse #covid-19 #gilead #patientaccess #remdesivir
PRICENTRIC BRIEF:
- The National Health Surveillance Agency (ANVISA) is in talks with Gilead to guarantee quick access to the antiviral Remdesivir for the treatment of patients who are hospitalized with COVID-19
- ANVISA already has mechanisms, including consent to use in a health care program and priority registration, prepared for Remdesivir pending initial data from clinical trials
- There has not yet been a request for authorization to use Remdesivir through Compassionate Use or Expanded Access assistance programs, said ANVISA
THE DETAILS
BRASILIA, Brazil – The National Health Surveillance Agency (ANVISA) is in talks with Gilead to guarantee quick access to the antiviral Remdesivir for the treatment of patients who are hospitalized with COVID-19.
ANVISA already has mechanisms, including consent to use in a health care program and priority registration, prepared for Remdesivir pending initial data from clinical trials.
Last week, Chairperson and CEO of Gilead Daniel O’Day revealed positive results obtained from the global, placebo-controlled trial of Remdesivir, in which patients with COVID-19 who received Remdesivir recovered fast from the coronavirus than similar patients who received placebo.
There has not yet been a request for authorization to use Remdesivir through Compassionate Use or Expanded Access assistance programs, said ANVISA.
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