Drugs Pharma

Indian regulator approves Aurobindo Pharma drug for lung, brain infections

Aurobindo Pharma DGCI, CDSCO, India

HQ Team

December 27, 2022: The Indian drug regulator had given its nod for Tergene, a joint venture of Aurobindo Pharma, to make a vaccine to fight pneumonia, meningitis, sinusitis and bronchitis.

In its meeting on December 21, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), the Subject Expert Committee (SEC) gave a green signal to manufacture and market a 15-valent pneumococcal polysaccharide conjugate vaccine.

The vaccine has a three-dose schedule for patients in the pediatric age group of 6, 10 and 14 weeks, according to a BSE filing.

PCV15 vaccine was developed by Tergene Biotech and manufactured at AuroVaccines, a wholly-owned subsidiary of Aurobindo Pharma Ltd.

One million children die

Diseases caused by streptococcus pneumoniae are a significant public health problem worldwide. In the developing world, young children and the elderly are most affected.

It is estimated that about one million children die of the pneumococcal disease every year, according to the WHO. About 90 distinct pneumococcal serotypes have been identified worldwide, with a small number accounting for most infections in infants.

Pneumococci are transmitted by direct contact with respiratory secretions from patients and healthy carriers. Serious pneumococcal infections include pneumonia, meningitis and febrile bacteraemia; otitis media, sinusitis, and bronchitis are more common but less severe manifestations. Pneumococcal resistance to antimicrobials is a serious and rapidly increasing problem worldwide.

Aurobindo Pharma holds an 80% stake in the joint venture company Tergene Biotech.

‘Safety, tolerability’

“SEC’s recommendation is based on data from (3+0) trial conducted in 1130 pediatric subjects assessing safety, tolerability, and immunogenicity,” said K. Nithyananda Reddy, vice-chairman and managing director of Aurobindo Pharma.

“By assessing opsonophagocytic activity (OPA) and Geometric Mean IgG Titers (GMTs), we have demonstrated through our clinical data that our test product is non-inferior to the currently available 13-valent pneumococcal conjugate vaccine for the thirteen shared serotypes and provided good immune response for the two additional serotypes unique to our vaccine (serotypes 2 and 12F),” Mr Reddy said. 

Aurobindo Pharma expects formal approval from DCGI in the coming weeks and will continue to develop the program for the WHO markets, thereby providing coverage and protection for more infants globally, he said.

The Drugs Controller General of India is responsible for issuing licences for specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera.

Aurobindo Pharma, headquartered in Hyderabad, India, develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients globally in over 155 countries.

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