Glenmark Pharmaceuticals has received approval from the Drug Controller General of India (DCGI) to evaluate antivirial drug favipiravir in clinical trials to treat patients with Covid-19.To get more news about Favipiravir, wisepowder official website is the best place for you.

Favipiravir is a generic version of Fujifilm Toyama Chemical's influenza drug Avigan, which holds approval in Japan for treating new influenza virus infections.Glenmark developed the drug's API and formulations internally. Following the regulatory approval, the new trial will assess the product in Covid-19 patients with mild to moderate infection.

Around 150 patients will be enrolled for the study. Participants will be given favipiravir plus standard supportive care or only standard supportive care.Treatment duration of the trial is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation.

Glenmark Pharmaceuticals Global R&D executive vice-president Sushrut Kulkarni said: "After having successfully developed the API and the formulations through its in-house R&D team, Glenmark is all geared to immediately begin clinical trials on favipiravir on Covid-19 patients in India.

"The clinical trial will let us know the efficacy of this molecule on Covid-19 patients. If the clinical trials are successful, favipiravir could become a potential treatment for Covid-19 patients."Last month, Fujifilm initiated a Phase II study of Avigan (favipiravir) to treat Covid-19 patients in the US. The trial will evaluate the drug's safety and efficacy as a potential Covid-19 therapy.

The company also commenced a Phase III trial of Avigan for the treatment of Covid-19 patients in Japan.In addition to treatment studies for Covid-19, Fujifilm is working to boost the production of Avigan to help fight the pandemic.

The drug is produced and distributed upon request by the government of Japan. Avigan was never distributed in the market and is not available at hospitals and pharmacies in Japan or internationally.

Mumbai-based Glenmark Saturday became the first pharmaceutical company in India to get approval for the manufacture and marketing of antiviral drug favipiravir, one of the medicines that is being explored as a potential treatment for Covid-19. To get more news about Favipiravir, wisepowder official website is the best place for you.

The Drugs Controller General of India had reportedly approved the medicine for "restricted emergency use" as Covid-19 treatment Friday. Glenmark said in a press statement as well as a media conference Saturday that the drug is advised for mild to moderate Covid-19 cases.

According to the company, the drug will be launched commercially next week and is likely to be available across chemist outlets, on prescription, by the end of the month. It will be priced at Rs 103 per tablet.

The antiviral medication was developed in Japan and subsequently approved for use among influenza patients. Favipiravir is among the drugs under trial for Covid-19 treatment along with Ebola drug remdesivir, a combination of HIV drugs lopinavir and ritonavir, as well as a combination of the latter two drugs with Interferon beta.

Currently, the drug is the subject of at least 18 clinical trials involving more than 3,000 patients across India, USA, Canada, Italy, China, France, UK and other countries. Early trials on the drug in China, involving 340 patients, produced encouraging outcomes in Wuhan and Shenzhen.

An 18 March report in The Guardian quoted a Chinese health official as saying that "the use of favipiravir showed definite improvements in lung condition in 91 per cent of the patients treated with it, compared to 62 per cent of those treated without the drug".

In another observational study involving over 2,000 patients with mild to moderate symptoms in Japan, those given favipiravir reportedly showed clinical improvement of up to 74 per cent by the seventh day and up to 88 per cent by the 14th day.

An outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its caused coronavirus disease 2019 (COVID-19) has been reported in China since December 2019. More than 16% of patients developed acute respiratory distress syndrome, and the fatality ratio was about 1%-2%. No specific treatment has been reported. Herein, we examine the effects of Favipiravir (FPV) versus Lopinavir (LPV)/ritonavir (RTV) for the treatment of COVID-19. To get more news about 259793-96-9, wisepowder official website is the best place for you.
Patients with laboratory-confirmed COVID-19 who received oral FPV (Day 1: 1600 mg twice daily; Days 2-14: 600 mg twice daily) plus interferon (IFN)-α by aerosol inhalation (5 million U twice daily) were included in the FPV arm of this study, whereas patients who were treated with LPV/RTV (Days 1-14: 400 mg/100 mg twice daily) plus IFN-α by aerosol inhalation (5 million U twice daily) were included in the control arm. Changes in chest computed tomography (CT), viral clearance, and drug safety were compared between the two groups. For the 35 patients enrolled in the FPV arm and the 45 patients in the control arm, all baseline characteristics were comparable between the two arms. A shorter viral clearance time was found for the FPV arm versus the control arm (median (interquartile range, IQR), 4 (2.5-9) d versus 11 (8-13) d, P < 0.001).
The FPV arm also showed significant improvement in chest imaging compared with the control arm, with an improvement rate of 91.43% versus 62.22% (P = 0.004). After adjustment for potential confounders, the FPV arm also showed a significantly higher improvement rate in chest imaging. Multivariable Cox regression showed that FPV was independently associated with faster viral clearance. In addition, fewer adverse reactions were found in the FPV arm than in the control arm. In this open-label nonrandomized control study, FPV showed significantly better treatment effects on COVID-19 in terms of disease progression and viral clearance; if causal, these results should be important information for establishing standard treatment guidelines to combat the SARS-CoV-2 infection.

Appili Therapeutics has secured regulatory clearance from Health Canada to move ahead with a phase 2 study for studying FUJIFILM Toyama Chemical's favipiravir as a preventative measure against the outbreak of novel coronavirus (Covid-19).To get more news about 259793-96-9, wisepowder official website is the best place for you.

e Canadian biopharma company expects to immediately begin recruitment for the mid-stage trial of favipiravir with an aim to enroll nearly 760 subjects from both residents and staff across 16 long-term care homes (LTCHs) in Ontario, Canada.

Allison McGeer, a senior clinician scientist at Sinai Health's Toronto-based Lunenfeld-Tanenbaum Research Institute will be the primary investigator of the phase 2 trial.

Allison McGeer said: "Given the severity of COVID-19 amongst the elderly, and the evidence of ongoing transmission with severe outcomes in LTCHs, it is critical to develop interventions that minimize the spread of disease in this setting. As vaccines and treatment for COVID-19 remain unavailable, we must explore all possible solutions.

"We look forward to working with Appili on this study, as the pandemic continues to present devastating consequences for LTCH residents and their families."

Designed as a broad-spectrum antiviral, favipiravir is approved in Japan under the Avigan brand name. Japanese health authorities granted approval in 2014 for FUJIFILM Toyama Chemical to use Avigan as a treatment and stockpile countermeasure for outbreaks of pandemic influenza.

According to Appili Therapeutics, the primary goal of its phase 2 clinical trial is to assess the efficacy of favipiravir for 25 days compared with placebo as prophylaxis against Covid-19 outbreaks in LTCHs.

The mid-stage trial's primary endpoint will be control of the outbreak which is defined as no new cases of Covid-19 in residents for 24 consecutive days up to Day 40 after the start of prophylaxis.Among the secondary objectives are measures of safety, infection rates, disease progression, and also fatality rates.

Appili Therapeutics chief medical officer Yoav Golan said: "With the strikingly high fatality rate from COVID-19 in long-term care facilities, there is a particularly urgent need to protect our most vulnerable members of society.

"Preventing and controlling COVID-19 outbreaks in long-term care facilities is therefore of extreme importance."Industry and academia are coming together in unprecedented ways to mitigate this crisis, and Appili is proud to be part of this unique collaboration."