Glenmark Pharmaceuticals, a international integrated pharmaceutical business, on Wednesday announced that the Post-Marketing Surveillance (PMS) study on Favipiravir in India has been completed effectively. The PMS study took spot in July last year to evaluate the security and efficacy of Favipiravir in mild to moderate covid-19 symptoms in patients, study the statement issued on Wednesday.
A total quantity of 1,083 patients took portion in the multicenter, open-label single-arm study and the study showed no issues with the usage of Favipiravir. The identified side effects of the Favipiravir– weakness, diarrhea, vomiting and weakness had been located mild in nature. While the time for fever resolution was located days, the time for clinical remedy was at least seven days.
The PMS study by Glenmark was one of its sort research performed in India on Favipiravir in mild to moderate covid patients. At least thirteen web pages, each from government and private institutions–Thiruvananthapuram, Nagpur, Nashik, Hyderabad, Mumbai, Bengaluru took portion in the study.
Alok Malik, Group Vice President & Head, Glenmark Pharmaceuticals stated that the study was critical as it examined the efficacy and security of the FabiFlu for world usage. The drug’s numerous variables can influence the outcomes. Despite all the aspects, the PMS study concluded that FabiFlu has the capacity to provide symptomatic relief and also increase the outcomes in these with mild to moderate covid-19 circumstances, he additional added.
The drug regulators of India, last year in June, authorized Favipiravir for the emergency use creating Glenmark the initially business to approve the oral medication for the patients with mild to moderate covid-19 symptoms. The drug was authorized last year due to the covid-19 led emergency in India.
The PMS study continued to evaluate the efficacy of Favipiravir even just after its launch. The typical age of patients in the study incorporated 40 per cent of ladies in the age group of 40, and guys at 60 per cent. Two varieties of popular comorbidities had been also noted in these patients– Hypertension and diabetes. The reports recommend that in the last one year, Indian drug corporations 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 remedy earlier this year.
Why was the drug removed from remedy?
The Union wellness and family welfare ministry earlier this year in June revised the remedy recommendations for covid patients and dropped the use of ivermectin, hydroxychloroquine, and the antiviral drug favipiravir from its list of advised remedy. The recommendations shared by the wellness ministry did not cite the use of any of these medicines which was utilised broadly by the physicians to treat patients.
The Indian Council of Medical Research (ICMR), on the other hand, prescribed the use of Ivermectin in specific quantities. The recommendations also recommended usage of other drugs like Remedesivir and Tocilizumab and the former to be utilised in choose moderate/serious hospitalised patients on oxygen inside 10 days of the illness.