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FDA Approvals for ‘First-of-Kind Drugs’ hit a 19-Year High in 2015

Update Date: Jan 05, 2016 10:41 AM EST

The U.S. Food and Drug Administration's (FDA) approval rate for novel drugs specifically nearly broke the all-time high record in 2015.

According to the numbers, the FDA approved a total of 45 novel drugs last year, which is just eight shy of the record of 53 that was set in 1996 and the highest since then. All 45 drugs, which were mainly manufactured for rare and hard-to-treat illnesses, included ingredients that have never been sold before.

The U.S. was not the only country that experienced increases in drug approvals. In the same year, the European Medicines Agency recommended 93 new products, which is higher than 2014's total of 82.

The increased approvals for specialty medications will most likely caused more debates about drug affordability.

Per the Boston Globe:

"While the trend toward specialty medicines is good news for industry and patients, it is likely to fuel the ongoing debate over rising prescription drug prices. That issue has become a top concern for consumers, a subject of congressional scrutiny, and even an issue on the presidential campaign trail. Democratic candidates Hillary Clinton and Bernie Sanders have both outlined proposals designed to curb prices.

The FDA is not allowed to consider prices when approving medicines, though some experts argue it should."

Reuters reported:

"But despite the rosy statistics and the prospect for further progress in 2016, the pharmaceuticals industry faces challenges, with increased political focus on drug pricing having punctured both biotech and specialty pharma valuations in recent months.

The prospect of Hillary Clinton becoming U.S. president could further undermine confidence in the sector's profitability in 2016, given her pledge to rein in drug costs."

The most expensive drug treatment regimen in 2015 was Orkambi, which is manufactured by Vertex Pharmaceuticals. A one-year supply of the drug that treats cystic fibrosis costs $259,000. Other drugs that come with a hefty price tag included new cancer drugs, such as Pfzier's Ibrance, which treats breast cancer.

Some of the novel drugs that were approved in 2015 included flibanserin (Addyi), which is used to boost women's sex drive and Amgen, Inc.'s Imlygic, used to treat melanoma.

Experts expect the approval rates for novel drugs to continue to increase with IMS Health estimating that from 2016 to 2020, there will be 225 new drug approvals.

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