Johnson & Johnson HIV Drug Gets Federal Approval
Federal regulators have given Johnson & Johnson approval for selling a new HIV medicine, which needs to be prescribed for patients receiving their first treatment.
Belonging to a category of drugs known as non-nucleoside reverse transcriptase inhibitors, the drug works by preventing the virus’s ability to replicate itself in the blood of the patient.
Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson, will be responsible for selling Edurant, the one pill a day drug.
Edward Cox, Director of the Food and Drug Administration’s Office of Anti-microbial Products said, patients respond in different ways to various HIV drugs, including experiencing varied side effects. By approving Edurant, FDA has provided patients starting HIV treatment with an additional treatment option.
Edurant’s becoming the new addition in the fight against HIV, will not only provide Johnson & Johnson with a potential blockbuster, but it will also hasten the process of coming up with an inexpensive version for patients in some of the poorest parts of the world.
Patients have to wait many years for a medicine approved in USA to become available in some of the world’s most HIV-prevalent areas, which is why agreements announced in February were made before Edurant was approved, to ensure a head start on marketing a generic medicine in sub-Saharan Africa, India and South Africa, at least 18 months earlier. In return for licensing rights to copy the drug, Tibotec will be paid royalties ranging from 2% to 5% by generic companies.
The agreements also target distribution of the new medicine in sub-Saharan Africa, Zimbabwe, Nigeria and Ethiopia, where there are 22.5 million people are living with HIV.
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