The US Food and Drug Administration has finally given dental a green light to start the process of making its first billion-dollar drug from scratch.
The agency has finally allowed a drug maker to start manufacturing a new type of cancer drug called Cigna’s BioPharma, which has the potential to be the world’s cheapest drug to treat patients with the most advanced cancer.
Cigna says it’s the first in a series of biologic medicines it’s working on for the elderly.
It’s currently in a phase 1 trial to treat glioblastoma, a brain tumor that has spread rapidly in recent years.
The FDA said it would review the biosimilar’s safety and efficacy for patients ages 50 and older, and to make a decision on whether to allow the drug to go to the market.
Cincinnati, Ohio-based BioPharmaceutical says it will begin selling its BioPharms in the US and Europe by the end of 2020.
The FDA’s move comes as the agency is grappling with a wave of opioid deaths and overdoses in the United States and abroad.
It also comes as several states are looking to expand access to prescription painkillers to lower opioid addiction rates.