Covid-19: Intas gets DGCI nod for hyperimmune globulin trials

Intas Pharmaceuticals Ltd on Wednesday announced that the company has received permission from the Drug Controller General of India (DCGI) to conduct clinical trials by using a newly-developed Covid-19-specific hyperimmune globulin. These are antibody-rich blood products made from blood donated by people who have recovered from the virus.

In a major breakthrough for Covid-19 treatment, the R&D team at Intas has developed hyperimmune globulin as treatment for patients suffering from moderate to severe Covid-19 infection.

Seen as an important therapeutic option to potentially help combat Covid-19 until a vaccine is made available, hyperimmune globulin has a potential for use as prophylaxis for all high-risk population in contact with Covid-19 patients.

Earlier, the US drug regulator US Food and Drug Administration (USFDA) had endorsed two investigational therapies derived from human blood which included convalescent plasma and hyperimmune globulin.

“There are some limited data to suggest that convalescent plasma and hyperimmune globulin may have benefit in the Covid-19 illness,” the USFDA had noted in April.

Alok Chaturvedi, Head of Medical and Regulatory Affairs, Intas, said that after establishing its usefulness in the clinical trials, the product will be made available for use in treating Covid-19 patients.

The company’s Head of Plasma Operations and Vice President, Suma Ray, said that hyperimmune globulin will provide purified and enriched preparation of Covid-19 specific neutralising antibodies in high concentration, free from blood transmitted viruses and other plasma proteins.

Ray added that it will also enable consistent, precise dosing and predictable response early in the treatment of Covid-19 infections.

Huge benefits

As the specific antibody treatment, it does not require blood group matching or donor selection while administering to the patient besides having huge benefits in terms of assured antibody administration.

Unlike plasma therapy, hyperimmune globulin can be readily administered to the patients anywhere even in the remotest part of the country.

Intas has started creating alliance with medical and research institutions, blood donation groups to collect the plasma from recovered Covid-19 patients. A website will also be launched to help recovered Covid-19 patients to locate the nearest Blood Bank where they can safely donate plasma.

The company has also sought government support to facilitate the supply of convalescent plasma for the manufacturing of these enriched hyperimmune globulin.

Intas commands expertise in blood plasma products through its wide range of Albumin, Immunoglobulins and Coagulation Factors used in the treatment of various life-saving conditions.

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