2 January 2020 - How many of the 'novel' drugs approved by the FDA in 2019 are actually new medicines in the 'real world?' 

For starters, 3 of the 48 are actually diagnostic agents. The first 'novel' medicine approved for the year was prabotulinumtoxinA-xvfs (Jeuveau). PrabotulinumtoxinA-xvfs was developed in South Korea from wild type Clostridium botulinum, resulting in a product of higher purity than onabotulinumtoxinA (Botox) (> 98% vs. 95%). From a real world perspective, I would say prabotulinumtoxinA-xvfs is an innovative new formulation. 

One could also argue that Accufer (iron maltol) is best described as an innovative new formulation of iron.

The FDA's official list does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2019 by the Center for Biologics Evaluation and Research (CBER). As such, the list needs to be interpreted with caution as it does not include 2019'w most talked about technology, the new gene therapy Zolgensma (onasemnogene abeparvovec) as well as the new vaccine for Ebolavirus (Ervebo). Insofar as submissions for new antisense oligonucleotides such as Vyondys 53 are assessed by the Center for Drug Evaluation and Research (CDER), they are not considered by the FDA to be gene therapies.

Read FDA novel drug approvals for 2019