NE BUSINESS BUREAU
MUMBAI, AUG 6
Drug firm Glenmark Pharmaceuticals on Thursday said it will launch a 400 mg version of oral antiviral drug FabiFlu for the treatment of mild and moderate COVID-19 in India.
Currently, the drug is available in 200 mg dosage.
The company, however, did not disclose the price at which it will be selling the drug.
The higher strength will improve compliance for patients by effectively reducing the number of tablets required per day, Glenmark said in a statement.
With the new 400 mg version, patients will now have a more relaxed dosage regimen, with 9 tablets required on Day 1 (4.5 in the morning and 4.5 in the evening), and thereafter 2 tablets twice a day from Day 2 till the end of the course, it added.
Glenmark is the first company in India to have received regulator Drugs Controller General of India’s approval for the 400 mg dosage form, the statement said.
“The 200 mg dosage of FabiFlu was developed in line with global formulations of the drug Favipiravir, which had similar strength. The 400 mg version is a result of Glenmark’s own R&D (research and development) efforts to improve the treatment experience for patients in India,” said Monika Tandon, vice-president, and head of clinical development, global specialty/branded portfolio at Glenmark Pharmaceuticals.
A higher pill burden has been associated with lower adherence to therapy, the latter affecting viral suppression and overall treatment outcomes. Also reducing the pill burden has been a demand from doctors and patients to enable adherence. The 200 mg dosage of FabiFlu required 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. With the new 400 mg version, patients will now have a more relaxed dosage regimen, with 9 tablets required on Day 1( 4.5 in the morning and 4.5 in the evening), and thereafter 2 tablets twice a day from Day 2 till the end of the course.
The company has also commenced a post-marketing surveillance study on FabiFlu to closely monitor the efficacy and safety of the drug in a large pool of patients prescribed with the oral antiviral Favipiravir, the statement said.
Glenmark is also conducting another Phase 3 clinical trial to evaluate the efficacy of two antivirals drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India. The combination study which is called the FAITH trial is looking to enrol 158 hospitalized patients of moderate COVID-19 in India. Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening the duration of virus shedding, facilitating early clinical cure, and discharge of patients.
