The current year is trending to a recent record for new drug approvals over the past few years. Thus far in 2011, the US Food and Drug Administration (FDA) has approved 21 drugs topping 2010’s total approvals. The FDA approved 21 new drugs in 2010 compared to 25 in 2009 and 21 approved in 2008. The number of new drugs approved has remained in the 20- 25 range by the FDA and European Medicines Agency (EMA) each during the past 4 years.
The FDA’s drug approval figures involve drugs or biologics that are made from living cells, which are considered to be new types of products. So far, new treatments have been approved for lupus (Human Genome Sciences’s Benlysta), melanoma (Bristol-Myers Squibb’s Yervoy), prostate cancer (J&J’s Zytiga), hepatitis C (Vertex’s Incivek) and Seizures (GSK and Valeant), to name a few. Also, in many cases, these new approved drugs offer a significant improvement over existing treatments.
There are still more than a dozen more drug candidates that are scheduled for review by year-end including, Seattle Genetics’ Adcetris (brentuximab vedotin), a first-in-class cancer drug, to treat cytotoxic payload. At this pace, the FDA is likely to approve more drugs this year than the previous years. The increase in drug approvals is part of a general improvement in the biopharmaceutical sector. We believe the performance of the life sciences industry this year is shaping up to be relatively strong.