Hitting a new record on drug approvals, the FDA offers a thumbs-up to another atopic dermatitis contender
Five years after little Leo Pharma put up its dukes and $115 million in cash to acquire and advance tralokinumab for atopic dermatitis, the Danish biotech has crossed the regulatory finish lines with a year-end approval at the FDA.
The drug will be sold as Adbry and there’s no immediate word on pricing.
This is the 50th new drug approval from CDER this year, totting up to 60 for the year if you add 10 major biologic OKs to the mix. That marks a record number of new approvals from the agency, tipping the scales after hitting 59 in 2020 and 2018. And it’s an indication that despite a long litany of setbacks in CMC in other areas, the drumbeat of new approvals continues at chart-topping levels after the long and disastrous dry spell of the early 2000s — despite a global pandemic.
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