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2015 Was A Bountiful Year For New Drugs

Approvals: FDA approvals could top last year’s record-high number

by Lisa M. Jarvis
December 7, 2015 | A version of this story appeared in Volume 93, Issue 48


This year brought a bumper crop of new drugs. With the Food & Drug Administration approving 40 novel therapeutics as of press time, 2015 is on track to surpass last year’s 41 new molecular entities—itself a two-decade high.

Once again, the lion’s share of the drugs were small molecules, with antibodies and peptides accounting for just 12 out of the 38 treatments approved. Cancer treatments made up the largest chunk of the new drugs approved. So far this year, 13 oncology treatments got FDA’s green light, surpassing the eight approved in 2014.

Among the notable new drugs was Vertex Pharmaceuticals’ Orkambi, a treatment for people with the ΔF508 mutation in the gene for cystic fibrosis transmembrane conductance regulatory protein, the most common cause of cystic fibrosis. And Novartis got the FDA nod for Entresto, a pill that combines the active ingredient in the older heart drug Diovan with the neprilysin inhibitor sacubitril. Annual sales of the heart failure drug are expected to eventually exceed $5 billion.

For some new drugs, the enthusiasm came not from their therapeutic or sales potential, but from the immediate financial reward the approval brought. Three treatments approved this year came with a priority review voucher (PRV), an incentive granted to drugs developed for certain tropical or rare pediatric diseases. The voucher, which is transferable, expedites FDA’s review of a future new drug.

The potential value of PRVs became clear this year when all three were sold for handsome sums. In August, AbbVie shelled out the largest amount—$350 million—for the PRV that came with the approval of United Therapeutics’ Xuriden, a treatment for a rare disease called hereditary orotic aciduria. AbbVie has not disclosed how it plans to use the PRV.

Gilead’s HIV treatment Genvoya includes the new ingredient tenofovir alafenamide.
Molecular structure of tenofovir alafenamide fumarate.
Gilead’s HIV treatment Genvoya includes the new ingredient tenofovir alafenamide.

The year also saw two vouchers used to speed the review of highly anticipated drugs. Sanofi and Regeneron used a PRV bought from BioMarin last year to get its PCSK9 inhibitor Praluent onto the market a month ahead of Amgen’s competing drug Repatha.

And Gilead Sciences applied a purchased PRV to Genvoya, a once-daily pill that combines three older HIV antivirals with tenofovir alafenamide fumarate, a prodrug that improves the delivery of tenofovir. Praluent, Repatha, and Genvoya are all expected to be multi-billion-dollar sellers in the coming years.


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