Glenmark says post-marketing study of COVID-19 antiviral Fabiflu supports the drug safety and effectiveness

moneycontrol ^ | 08 Jun, 2021 | Visawanath Pilla

[nickcarraway]

"The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day seven," Glenmark said.

Glenmark on June 8 said that the interim data of the Post Marketing Surveillance (PMS) study on COVID-19 antiviral drug Fabiflu (Favipiravir) in India, supports the drug safety and effectiveness in real world settings with no new safety signals or concerns in Covid-19 patients

"The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day seven," Glenmark said.

Glenmark PMS interim data was based on 503 patients.

The PMS study commenced in July 2020 aimed to evaluate safety and efficacy of Favipiravir in mild to moderate Covid-19 patients. As on date, a total of 1083 patients have been enrolled in the prospective, open label, multicenter, single arm study. A total of 13 sites – both Government and private institutions – across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum took part.

The mean age of patients was 40 years, with the most common age group being 30-45 years. Women comprised 40 percent, while men 60 percent of the study population. Hypertension and Diabetes were the two most common comorbidities noted in these patients.

Fever was present in all patients at baseline followed by cough (84.6 percent), fatigue (55 percent), new loss of taste (38.1 percent).

Glenmark submitted the to the data to the regulator.

On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from DCGI for Favipiravir 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.

Fabiflu has been money spinner for Glenmark with clocking sales of Rs 352 crore in April 2021 alone, accounted for over 2 per cent of the total domestic pharma market sales of Rs 15,662 crore in that month.

“It is encouraging to note that our interim data supports the safety and effectiveness of FabiFlu (Favipiravir) in real-world settings," said Alok Malik, Group Vice President & Head, India Formulations, of Glenmark said.

"Since its launch last year, FabiFlu has provided immense relief to millions of patients in India and the world, while also reducing the overall burden on healthcare infrastructure. We will soon submit the final studyfindings to the regulator and continue to deliver FabiFlu’s multiple benefits to patients all over,” Malik said.

[BobL]

Sounds like they’ve figured out a way to re-package Ivermectin and charge 50 times the price - so therefore this treatment can now be used.