The oral treatment from the company’s HIV unit, ViiV Healthcare, has been approved for adults whose HIV infection could not be successfully treated with other therapies due to resistance, intolerance or safety considerations, the agency said.
Zydus has received approval from Indian regulators to begin human studies for its COVID-19 vaccine contender, the drugmaker said on Friday, as the novel coronavirus infections continue to surge in the world’s fourth worst-hit nation.
The potential vaccine showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralize the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement to Indian stock exchanges.
India’s approval for Zydus comes days after privately held Bharat Biotech got a similar green light for human studies for its vaccine candidate.
Zydus will begin human trials this month in over 1,000 subjects in multiple sites in India, it said. The company also plans to ramp up its production capacity for the vaccine contender to serve Indian and global demand, it added.
There were no safety concerns for the vaccine candidate in repeat dose toxicology studies, Zydus said. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.