Pharmaceutical announces endorsement by Anvisa to test medicine for covid-19 in Brazil

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The American company Sorrento Therapeutics informed this Wednesday (14.out.2020) that Anvisa (National Health Surveillance Agency) authorized the 2nd phase of clinical tests of the drug Abivertinib in mild, moderate and severe cases of covid-19, disease caused by the new coronavirus.

The drugmaker hopes to test about 400 people. The dose applied will be the same as the equivalent stage of testing in the United States. The duration, however, will be different: 7 days. In the United States, tests are focused on serious cases and administration of the drug lasts 14 days, the statement said. Read the full text (38 KB).

Sorrento also informs that it expects to obtain 400 subscribers quickly because of the partnership with Synova Health, a clinical research institution with access to medical centers across the country. It says 1 “Broad medical alignment”including the city of Rio de Janeiro will also help speed up the start of tests.

Anvisa, in turn, stated that “Anvisa’s official statement regarding the consent or not of any clinical research occurs exclusively through publication in the Federal Official Gazette (DOU), which has not yet occurred for the case in question”.

WHAT IS PHASE 2 OF CLINICAL TESTING

According to the Faculty of Medical Sciences at Unicamp (State University of Campinas), in São Paulo, clinical research usually has 4 phases:

  • Phase 1 – when the drug is tested for the first time on human beings, generally healthy individuals to test the drug’s administration routes, interaction with other drugs and alcohol and dosage. 20 to 100 people usually participate;
  • Phase 2 – when the drug is applied to people with the disease to be treated to assess the drug’s efficacy and safety. From 100 to 300 people usually participate;
  • Phase 3 – the drug is now applied to thousands of patients (usually between 5,000 and 10,000) and is tested for longer. In this step, we seek to expand information on the safety, efficacy and interaction of the substance. Performance is also compared with other existing treatments. It is here that it is already possible to obtain registration and clearance for sale from health authorities;
  • Phase 4 – performance is monitored to identify any unidentified collateral damage. Also performed with thousands of patients.

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