FDA and EMA Novel drug approvals 2022

Throughout 2022 we have seen a decrease in the number of novel drugs approved by the FDA and EMA compared to previous years. So far in 2022, 16 new drugs were approved by the FDA, a major decrease from the previous year, in which 27 new medicines were approved till July and 50 approved throughout the year. The trend seems to be similar in the EU, where 12 new medicines were approved by the EMA, compared to 20 approvals by the same time last year.
The one drug that stands out in terms of projected sales is Mounjaro, a treatment for adults with type 2 diabetes marketed by Eli Lilly. This treatment has been approved by the FDA in May, and has been recommended for market authorization by the EMA’s human medicines committee (CHMP) in July. Mounjaro proved efficient in the treatment of type 2 diabetes, and according to Eli Lilly, has also helped obese recipients lose over 20 percent of their body weight. The peak revenue for this drug is projected to reach between 8-20$ billion, depending if the drug will be used as a treatment for obesity as well as diabetes.

The following table portrays drugs approved by the FDA in 2022, and their status regarding the EMA:

FDA and EMA Novel drug approvals 2022

Pharma14 tracks all new approvals in 68 countries. Tracking pricing levels consumption and much more.
Sample Pharma14 data: Mounjaro/Tirzepatide federal tender and state purchase level ex-factory prices.

FDA and EMA Novel drug approvals 2022


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Drug Price