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Glenmark says FabiFlu shows positive results in Phase 3; mild, moderate COVID-19 cases improved faster

Coronavirus treatment: Patients who were administered Glenmark's FabiFlu saw 40 per cent faster achievement of clinical cure

twitter-logoBusinessToday.In | July 22, 2020 | Updated 17:35 IST
Glenmark says FabiFlu shows positive results in Phase 3; mild, moderate COVID-19 cases improved faster
Coronavirus treatment: FabiFlu shows positive result

Glenmark says FabiFlu showed promise in a late-stage study. The study was conducted on 150 patients with mild to moderate coronavirus infection. The company said that 69.8 per cent of patients achieved "clinical cure" by the fourth day of the study as compared to 45 per cent in the group that was treated with standard supportive care.

Patients who were treated with FabiFlu -- Glenmark's version of favipiravir -- saw 28.6 per cent faster viral clearance. Patients who were administered FabiFlu saw 40 per cent faster achievement of clinical cure. Clinical cure is derived after an assessment of temperature, oxygen saturation, respiratory rate and cough in the patient.

"Patients randomised to Favipiravir seemed to have faster clinical cure, and more importantly, faster viral clearance than those randomised to the routine care group. I eagerly await the final analysis and results from other ongoing studies from across the globe. Till then, I feel we have enough evidence to consider using Favirpiravir in symptomatic COVID-19 patients who have mild to moderate infection," said one of the principle investigators of the study Dr Zarir Udwadia.

Among the ones who deteriorated even after FabiFlu saw a delayed need of oxygen support.  The drug was well tolerated with no serious adverse events (SAE) or deaths. The company said that AEs were reported in 26 patients (35.6 per cent) who were administered FabiFlu as against six patients (8 per cent) in the patients who were not administered the drug. However, the AEs were mild to moderate and none led to discontinuation of the dosage.

Patients in the trial were administered FabiFlu tablets of 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, along with standard supportive care.

Meanwhile, Glenmark responded to the DCGI's notice that alleged that the drug FabiFlu was overpriced and cannot be purchased by common people. In a letter to DCGI, Glenmark said FabiFlu is much more economical and effective when compared to other drugs. The estimated total cost of therapy for full course is only Rs 9,150, when compared to the prices of Remdesivir (Rs 24,000-30,000), Tocilizumab (Rs 44,000) and Itolizumab (Rs 32,000). Moreover, it added that FabiFlu is an oral therapy and patients need not be hospitalised for the drug course.

Also read: FabiFlu 'cheapest' COVID-19 drug; Glenmark calls overpricing charge baseless

Also read: DCGI sends show cause notice to Glenmark over 'false claims', steep pricing of FabiFlu

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