2018 Drug Approvals

Of the record 59 FDA drug approvals from 2018, the majority were small molecules (64%). Keep at it, chemists! ūüôā Oncology and infectious diseases were the areas with most small molecule approvals, followed by genetic/rare diseases. Some more statistics below.

Last year the FDA approved a record 59 novel drugs, which included 38 small molecule drugs, 18 biologics, and 3 which don’t really belong to either class (Lokelma, an inorganic potassium binder, Omegaven, a fish-oil based IV nutrient, Lutathera, a lutetium-based radiotherapeutic). Given all the activity in biologics in the last few decades, it’s surprising to see that small molecules still outnumber biologics among new approvals. What’s really amazing is the diversity of non-small molecule therapies. Of the 18 biologics approved, 11 are antibodies, 3 are enzymes, 2 are immunotoxins, 1 is an siRNA, and 1 is an anti-sense oligonucleotide. And this doesn’t include vaccines, cell therapies, or gene therapies, which are categorized separately from drugs by the FDA.

Small molecules made up the majority of 2018 approvals.  Out of a total of 59, 38 are small molecules, 18 are biologics, and 3 are neither.

It’s probably no surprise to those working in biopharma that oncology is the largest indication by approvals for both small molecules and biologics, or that rare diseases were a large percentage of 2018 drug approvals. For small molecules, it’s more surprising to see infectious diseases as the second-largest source of approvals, with only two drugs (Pifeltro and Biktarvy) attributable to the big viral indications (HIV, HCV). The rest of the anti-infective drugs are primarily for conditions rare in the western world including river blindness, malaria, and traveler’s diarrhea. Included in this cohort is the drug Tpoxx, a pill for smallpox. That we need new drugs for smallpox when everyone in the world should be getting vaccinated is a story of its own.

Oncology was the disease area with the largest number of approvals for both small molecules and biologics.  

In contrast, only one biologic drug was approved last year for infectious diseases (ibalizumab, a CD4-binder for treating HIV infection). A larger number were approved for rare genetic diseases, such as pegvaliase for phenylketonuria. The third-largest indication for biologics, neurology, was primarily due to the simultaneous approval of three CGRP modulators for migraine prevention (erenumumab, fremanezumab, and galcanezumab).

There’s a lot more interesting stuff in last year’s new drug approvals cohort, and we’ll take a more technical look at some of these drugs in some later posts ‚ÄĒ stay tuned!

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