What’s new in the market: the 2015 FDA drugs approval


Another year has gone and forty-five new drugs have been approved by FDA. A nice analysis has been published by Asher Mullard in Nat Rev Drug Disc 2016, 15, 73-76, providing the statistic related to these new drugs (for the complete list see Table 1 in the paper).

2015 was a very prolific year with double approval rate with respect to the period 2005-2009 and with rejections at an all-time low, with only two drugs not been approved.

Twenty-five drugs were filed with a priority review (FDA will take action within six months from the filing compared to ten months for the standard filing), ten with a breakthrough status (status given to speed up the development and approval of drugs with significant advances over approved therapy), six with an accelerated approval (status given to drugs used to treat unmet medical need disease).

Figure 1 reports the percentage of approvals for each therapeutic area. Oncology played a big role with 1/3 of the approved drugs indicated for this therapeutic area.

Figure 1

Figure 1. Pie chart indicating the newly approved drugs divided by therapeutic area.

Of particular interest is Palbociclib, a first-in-class CDK4/CDK6 inhibitor developed by Pfizer for the treatment of hormone-receptor-positive advanced breast cancer, which has received accelerated and breakthrough designation status; forecast sales are predicted to be in the region of $5 billion per year by 2020; other predicted blockbusters are indicated in Figure 2, including two monoclonal antibodies: Alirocumab and Evolocumab, first-in-class inhibitors of PCSK9, a protein involved in the regulation of blood cholesterol level. Forecast sales for these two drugs are expected to be over $2 billion per year. In total over a third of the approved drugs are expected to be blockbusters.

Figure 2

Figure 2. Forecast blockbusters.

Twenty-one of the approved drugs have an indication for orphan diseases, of which about 50% are anticancer drugs, indicating the success in developing new and more selective anticancer agents, including four drugs to treat multiple myeloma.

Looking at 2016 potential new approval, forty New Molecular Entity and Biologics Licence Application were filed in 2015. A selection of these potential new drugs is reported in Figure 3.

Figure 3

Figure 3. New drugs seeking approval in 2016

This includes Eteplirsen, a first exon-skipping oligonucleotide for the treatment of Duchenne muscular dystrophy and Venetoclax, a first-in-class BCL-2 inhibitor for the treatment of chronic lymphocytic leukaemia.

We will find out their destiny during this year; keep a eye on our blog!

Blog written by Marco Derudas

 

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