By: Mahiyan Chakrabarti

Gufic Biosciences Limited (Gufic), a well-known name in the Pharmaceutical industry, has recently added yet another feather to its cap, as it has received permission from Central Licensing Approving Authority, Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare for manufacture, sale and distribution of IsavuconazoniumSulfateAPI and finished formulation Isavuconazole for Injection 200 mg/vial. Isavuconazole for Injection 200 mg/vial is indicated for the treatment of patients who are 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis.

Mr. Nagesh Y., Chief Operating Officer, Gufic Biosciences Ltd said that, Isavuconazole is a systemic antifungal drug of triazole class which is already approved by US-FDA on March 06, 2015 and European Medicines Agency (EMA) on October 15, 2015. The incidence of invasive fungal infections has been increasing over the past few decades and represents a significant problem in immunocompromised individuals and a large proportion of critically ill patients. During the second wave of Covid-19, it was found that there has been a significant increase in number of cases of Mucormycosis in covid-19 patients across India who showed the symptoms of this acute fungal infection during treatment in hospitals and after discharge. This is where Isavuconazole has come as a boon for these patients.

Isavuconazole has activity acted against Aspergillus, Mucorales and other rare mould infections, enabling physicians to treat the patients without a confirmed diagnosis. Isavuconazole has a broad spectrum of activity, comparable efficacy, favourable safety profile, improved ease-of–use, which means that it is a valuable treatment option for those with possible invasive aspergillosis or mucormycosis, particularly in patients who may be immunocompromised, taking multiple therapeutic agents and are unable to tolerate treatment with high organ toxicity.

Dr. Adarsh Shetty, General Manager – Medical Affairs said that, the second wave of Covid-19 in early 2021, had caused devastating chaos in India. Mucormycosis or Black Fungus an invasive fungal infection in Covid-19 patients had posed a big challenge towards the medical fraternity and a high death rate was reported in this scenario. There was an urgent need of an effective antifungal drug to fight this life-threatening condition. There are only a limited number of approved therapies for the treatment of invasive aspergillosis and mucormycosis. According to a recent multinational study it was found that as many as 15 percent of patients with Covid-19 who are hospitalized in an ICU develop Aspergillus infection. Damage to the lining of airways from severe SARS-CoV-2 infection allows Aspergillus fungi to invade the tissue. Isavuconazole, a first-line of therapy has come as a saviour for these patients. It has become the need of the hour to have an effective and safe drug in the antifungal category to fight invasive fungal infections. “The overall invasive fungal infections incidence rate varies from 3% to 20%. The ongoing covid-19 pandemic has also brought the focus back on superinfections caused by secondary invasive fungal infections. Opportunistic pathogens such as Candida sp., causing candidiasis, Aspergillus sp., causing Aspergillosis and Mucorales causing Mucormycosis (Black Fungus) are the most common causative agents of these infections. Mucormycosis and Aspergillosis typically affect the immunocompromised or already critically ill individuals, both infections can be highly fatal, with mortality rates approaching 90%. The prevalence of mucormycosis is around 70 times higher in India than it is globally. Diabetes mellitus is the most common risk factor, followed by haematological malignancy and solid-organ transplant. Invasive aspergillosis and mucormycosis are also associated with lengthy hospital stays, and impose substantial healthcare costs, driven by prolonged treatment and management of treatment-related adverse events. This increases mortality rates and contributes to the economic burden of invasive aspergillosis and mucormycosis. There are only a limited number of approved therapies for the treatment of invasive aspergillosis and mucormycosis.

Dr. Adarsh Shetty further added that, the overall invasive fungal infections incidence rate varies from 3% to 20%. The ongoing covid-19 pandemic has also brought the focus back on superinfections caused by secondary invasive fungal infections. Opportunistic pathogens such as Candida sp.- causing candidiasis, Aspergillus sp.- causing Aspergillosis and Mucorales causing Mucormycosis (Black Fungus) are the most common causative agents of these infections. Mucormycosis and Aspergillosis typically affect the immunocompromised or already critically ill individuals Both the infections can be highly fatal, with mortality rates approaching 90%. The prevalence of mucormycosis is around 70 times higher in India than it is globally. Diabetes mellitus is the most common risk factor, followed by haematological malignancy and solid-organ transplant. Invasive aspergillosis and mucormycosis are also associated with lengthy hospital stays, and impose substantial healthcare costs, driven by prolonged treatment and management of treatment-related adverse events. This increases mortality rates and contributes to the economic burden of invasive aspergillosis and mucormycosis. There are only a limited number of approved therapies for the treatment of invasive aspergillosis and mucormycosis.

With much relief and lot of  optimism, Isavuconazole is expected to serve the patients affected with these acute fungal infections. Gufic has a unique legacy of bringing forward ground-breaking innovations in the field of infectious diseases by bringing innovative medicines rapidly, which provide the patients to live with improved living conditions.

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