Glenmark Pharmaceuticals Reports More Positive Favipiravir Data Associated with COVID-19 Pandemic
Will Western Media Pick up?
Glenmark
recently announced the interim data of 503 patients from its Post Marketing Surveillance (PMS) study on Favipiravir in India.
This study started back in July 2020
with the goal of evaluating the safety and efficacy of the antiviral in mild to moderate COVID-19 patients.
The first and largest of post-marketing studies now underway in India
involving Favipiravir in mild to moderate SARS-CoV-2 infections, a total of 1083 patients were enrolled in the prospective, open-label, multicenter, single-arm study
involving 13 government and private trial sites across
Mumbai,
Bangalore,
Hyderabad,
Nashik,
Nagpur,
and Trivandrum.Thus far, the data is quite promising, revealing no new safety signals or concerns with the use of the study drug (currently authorized on an emergency basis)
and known side effects such as
weakness,
gastritis,
diarrhea,
vomiting, etc.
which were found to be mild.Glenmark reports that
the time to fever resolution was reported on day 3, while two-thirds of the patients achieved clinical cure by day 7.
TrialSite emphasizes that
these antivirals are used in many nations yet in places such as North America and Europe, the press barely mentions the use of this now generic drug.
the drug
is authorized for use in India and several other countries including Russia.With a mean age of 40, the most common study age cohort was 30 to 45 years of age.
The study included 40% female and 60% male subjects.
The two most common comorbidities included hypertension and diabetes.
At baseline,
the study teams found fever present in all patients along with cough (84.6%), fatigue (55%) and new loss of taste (38.1%).