Glenmark’s Fabiflu is the first oral Favipiravir-approved medication for the treatment of COVID-19 and has been launched in few centers. The Drug Controller General of India approved the anti-viral for ‘restricted emergency use’ for treatment of mild to moderate cases, which accounts for a majority of COVID-19 infections. DCGI’s approval was based on Glenmark’s phase 3 clinical trials of a randomized, multi-centric study at 11 sites in India to test efficacy and safety of Favipiravir.
“The drug will be available both in hospitals and in retail chemist stores by next week and will be available only on a doctor’s prescription, who will be first taking patients’ consent before starting the the drug,” said Sujesh Vasudevan, president – India Formulations, Glenmark Pharmaceuticals.
Favipiravir is also approved for compassionate use in Japan and nearly 2,050 patients have already been administered Favipiravir. “Japan’s clinical use showed high recovery rates at both 7 days (74 percent) and 14 days (88 percent) of therapy in both mild and moderate patients.”
Another study in 390 patients in Russia showed 68 percent of those on Favipiravir reached fever resolution on day 3 versus day 6 for those on standard therapy. Favipiravir is also approved by Italy and China for experimental use/compassionate use in COVID-19 and few countries in the Middle East.
Safety information:
Favipiravir is an antiviral previously indicated for influenza and Ebola.
As per article published in NCBI based on review of clinical safety data of Favipiravir from 32 studies, “Favipiravir demonstrates a favourable safety profile regarding total and serious AEs. However, safety concerns remain: hyperuricaemia, teratogenicity and QTc prolongation have not yet been adequately studied. Favipiravir may be safe and tolerable in short-term use, but more evidence is needed to assess the longer-term effects of treatment.”
Contraindications:
The drug should not be prescribed to patients with severe renal, hepatic impairment, pregnant and lactating women (teratogenic and early embryonic deaths were identified in animal studies).
The drug is also contraindicated in patients with history of hypersensitivity to Favipiravir and those with history of having Gout or uric acid imbalances.
Precautions:
The administration should be started promptly after the onset of influenza-like symptom.
AVOID SELF MEDICATION.
Reference: https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.cdc.gov.tw/File/Get/ht8jUiB_MI-aKnlwstwzvw&ved=2ahUKEwiJyJq6tJLqAhUiyzgGHQ3zBsY4ChAWMAB6BAgHEAE&usg=AOvVaw05Pbn8xefB0ZoIO4HEC3Gz
Leave a Reply