Happy New Year, everybody.
And with the new year comes the annual report from the FDA/CDER on novel drug approvals.
CDER approve8 48 novel candidates in 2019, down from the 59 approvals in 2018, but comparable to the 45 approvals in 2015 and 46 approvals in 2017.
The entire list of novel products approved in 2019 is available here.
The page also has a link to a detailed 40+ page report from CDER.
This list excludes the 21 BLA approvals managed by CBER. Those approvals are available here.
We encourage you to take a look at the report, as it has some interesting discussion on the various products approved.
Here are a few which stand out for us:
Migraine – We had not one, but two approvals in 2019 for acute migraine. In October, the FDA approved lasmiditan (Reyvow, Lilly). This compound came to Lilly via their acquisition of CoLucid in 2017. In December, ubrogepant (Ubrelvy, Allergan) was approved, even with the liver tox issues associated with CGRP Inhibitors, which is becoming an increasingly competitive market. .
Anti-Infectives – Multiple anti-infectives were approved in 2019, including cefiderocol (Fetroja, Shionogi), for Gram-Negative bacterial infections. Its first indication is complicated urinary tract infections in patients with limited or no alternative options. Lefamulin (Xenleta, Nabriva) was approved in August for Community Acquired Pneumonia. Pretomanid was approved in August for drug-resistant tuberculosis, and is the second drug approved under the Limited Population Pathway for Anti-bacterial/Anti-fungal Drugs, or LPAD pathway.
Others of Note – We have new drugs to treat insomnia, excessive daytime sleepiness (which is not a controlled substance), and ten new drugs to treat various cancers.
What can we expect in 2020?
Predicting what a regulatory agency might or might not do is a difficult game to play…and we won’t even try to predict what will or will not receive FDA approval in 2020. But what we can say is, according to Biomedtracker, there are ~160 drug candidates with PDUFA dates in 2020 (email us if you want the list). Of these, roughly 60 of them will be experiencing a First Review by the FDA. So we could be looking at another excellent year for approvals in 2020. Then again, the probability of success at the Regulatory stage is not 100%, is it?!