Friday, Apr 26 2024 | Time 02:45 Hrs(IST)
image
Business EconomyPosted at: Sep 15 2021 1:33PM


Glenmark concludes PMS study on Favipiravir in 1000+ COVID-19 patients

Mumbai, Sep 15 (UNI) Pharma major, Glenmark Pharma on Wednesday announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu) in India.
The PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in patients with mild to moderate form of COVID-19, a company release said.
A total of 1083 patients were enrolled in the prospective, open label, multicentre, single arm study. 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's PMS study is the first and largest post marketing study conducted in India on Favipiravir in patients with mild to moderate form of COVID-19. Thirteen sites - both Government and private institutions - across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum participated. The study was conducted in patients in line with the approved indication of the drug.
Commenting on these findings, Mr Alok Malik, Group Vice President & Head, India Formulations, said, "This study was crucial as it examined the safety and efficacy of FabiFlu® in real-world settings, where multiple variables can impact the results. Despite these factors, the PMS study demonstrated FabiFlu®s consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate COVID-19. It is a step forward both for Glenmark and the medical community, as it reinforces the oral antiviral's multiple benefits in tackling the pandemic."
On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from India's drug regulator for Favipiravir (FabiFlu®), making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19. The approval was granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.
This PMS study continued to evaluate the safety and efficacy of Favipiravir (FabiFlu) post its launch in the market. The average age of patients in the study was 40 years, with women comprising 40 per cent, while men 60 per cent of the study population. Hypertension (11 per cent) and diabetes (8 per cent) were the two most common comorbidities noted in these patients. All the patients had baseline fever, followed by cough (81 per cent), fatigue (46.2 per cent), and new loss of taste (41 per cent).
UNI JS ACL1332
Please log in to get detailed story.
Tags: #Glenmark concludes PMS study on Favipiravir in 1000+ COVID-19 patients
More News

Arun Alagappan appointed as Executive Chairman of Coromandel International

25 Apr 2024 | 7:41 PM

Hyderabad, April 25 (UNI) Arun Alagappan has been appointed as Executive Chairman of Coromandel International Limited (CIL).

see more..

Tech Mahindra net at Rs 661 crore in Q4; Company gives dividend of Rs 28 per share

25 Apr 2024 | 7:28 PM

New Delhi, April 25 (UNI) Mahindra Group company Tech Mahindra, a technology consulting and digital solutions provider, on Thursday reported about 41 per cent decline in net profit at Rs 661 crore year-on-year basis for the fourth quarter ended March 31, 2024.

see more..

Kottayam-Kochi Rubber Market Rates

25 Apr 2024 | 7:26 PM

Kottayam, April 25 (UNI) Following were the Rubber Market rates announced by the Rubber Board here today per quintal.

see more..
Indusind Bank net up 15 pc in Q4

Indusind Bank net up 15 pc in Q4

25 Apr 2024 | 7:10 PM

New Delhi, April 25 (UNI) Leading private bank Indusind on Thursday reported a 15 percent jump in net profit at Rs 2,349 crore in Q4 of FY 2023–24, compared to Rs 2,043 crore in the same quarter in 2022–23.

see more..

25 Apr 2024 | 6:53 PM

New Delhi, April 25 (UNI) Leading private bank Indusind on Thursday reported 15 percent jump in net profit at Rs 2,349 crore in Q4 of FY 2023-24 compared to Rs 2,043 crore in the same quarter in 2022-23.

see more..
image