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Drugmaker Glenmark Pharmaceuticals says its surveillance on anti-viral Favipiravir in real world settings was consistent with earlier findings that it provided symptomatic relief and improved clinical outcomes in patients with mild to moderate Covid-19.
The Mumbai-based drugmaker was the first to get an emergency use approval on this oral drug in June last year, and its latest statement follows the completion of its Post Marketing Surveillance (PMS) study on Favipiravir (sold as FabiFlu) in India.
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The PMS study commenced in July 2020 to evaluate safety and efficacy of Favipiravir in mild to moderate Covid-19 patients and a total of 1,083 patients were enrolled in the prospective, open label, multicentre, single arm study, a note from the company said. Thirteen sites were enrolled in the study, both Government and private institutions, and across Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur, and Thiruvananthapuram.
“Results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects such as weakness, gastritis, diarrhoea, vomiting etc., were found to be mild in nature. The time for fever resolution was 4 days, while time for clinical cure was 7 days,” Glenmark said.
Presently, a host of Indian drugmakers also produce this drug, including Hetero, Sun Pharma, Cipla, Dr Reddy’s Laboratories, BDR and so on.
Study details
Alok Malik, Glenmark’s Group Vice President & Head (India Formulations), said, the study was crucial “as it examined the safety and efficacy of FabiFlu® in real-world settings, where multiple variables can impact the results.”
Glenmark to launch higher strength Favipiravir to reduce pill-burden to patients
Glenmark’s original approval was for FabiFlu (200 mg) that requires patients to take 18 tablets on Day 1 (nine in the morning and nine in the evening), followed by 8 tablets each day thereafter for a maximum of 14 days. The company has since reduced the “pill burden” with a 400 mg version and a combination pack that also has an 800 mg version. The PMS study involved all three versions, a company spokesperson said.
Giving details on the study, Glenmark said the average age of patients in the study was 40 years, with women comprising 40 per cent of those reviewed. Hypertension (at 11 per cent) and diabetes (8 per cent) were the two most common co-morbidities noted in these patients, it said. Fever was present in all patients at baseline, followed by cough (81 per cent), fatigue (46.2 per cent), and new loss of taste (41 per cent), it added.
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