The PMS study by Glenmark was one of its kind studies conducted in India on Favipiravir in mild to moderate covid patients.
Glenmark Pharmaceuticals, a global integrated pharmaceutical company, on Wednesday announced that the Post-Marketing Surveillance (PMS) study on Favipiravir in India has been completed successfully. The PMS study took place in July last year to evaluate the safety and efficacy of Favipiravir in mild to moderate covid-19 symptoms in patients, read the statement issued on Wednesday.
A total number of 1,083 patients took part in the multicenter, open-label single-arm study and the study showed no concerns with the usage of Favipiravir. The known side effects of the Favipiravir– weakness, diarrhea, vomiting and weakness were found mild in nature. While the time for fever resolution was found days, the time for clinical cure was at least seven days.
The PMS study by Glenmark was one of its kind studies conducted in India on Favipiravir in mild to moderate covid patients. At least thirteen sites, both from government and private institutions–Thiruvananthapuram, Nagpur, Nashik, Hyderabad, Mumbai, Bengaluru took part in the study.
Alok Malik, Group Vice President & Head, Glenmark Pharmaceuticals said that the study was crucial as it examined the efficacy and safety of the FabiFlu for world usage. The drug’s multiple variables can impact the results. Despite all the factors, the PMS study concluded that FabiFlu has the ability to provide symptomatic relief and also improve the outcomes in those with mild to moderate covid-19 cases, he further added.
The drug regulators of India, last year in June, approved Favipiravir for the emergency use making Glenmark the first company to approve the oral medication for the patients with mild to moderate covid-19 symptoms. The drug was approved last year due to the covid-19 led emergency in India.
The PMS study continued to evaluate the efficacy of Favipiravir even after its launch. The average age of patients in the study included 40 per cent of women in the age group of 40, and men at 60 per cent. Two types of common comorbidities were also noted in these patients– Hypertension and diabetes. The reports suggest that in the last one year, Indian drug companies sold emergency drugs to treat covid patients worth more than Rs 2,600 crore. Favipiravir, alone, made it to 50 per cent of the total sales worth Rs 1,300 (Nearly). The drug was dropped from treatment earlier this year.
Why was the drug removed from treatment?
The Union health and family welfare ministry earlier this year in June revised the treatment guidelines for covid patients and dropped the use of ivermectin, hydroxychloroquine, and the antiviral drug favipiravir from its list of advised treatment. The guidelines shared by the health ministry did not cite the use of any of these medicines which was used widely by the doctors to treat patients.
The Indian Council of Medical Research (ICMR), however, prescribed the use of Ivermectin in certain quantities. The guidelines also suggested usage of other drugs like Remedesivir and Tocilizumab and the former to be used in select moderate/severe hospitalised patients on oxygen within 10 days of the disease.