The first drug approved by FDA of USA, that was produced through genetic engineering was
The first drug approved by FDA of USA, that was produced through genetic engineering was
Select an option to attempt
Correct Answer: Option B
Explanation
Humulin (recombinant human insulin) was approved by the US FDA on 29 October 1982, making it the first human therapeutic protein produced by genetic engineering to receive regulatory approval. It was developed by Genentech and licensed to Eli Lilly. The human insulin A and B chains were expressed separately in E. coli from synthetic genes containing the human insulin coding sequences, then combined in vitro to form functional insulin. Previously, diabetics used porcine or bovine insulin (1–2 amino acids different from human), causing allergic reactions in some patients. Human recombinant insulin eliminated this problem and is now produced by yeast (Saccharomyces cerevisiae) as a single precursor.