2012: Landmark Year for Drug Approvals

Mar 28, 2013
The FDA hit a 15-year high for drug approvals in 2012, with new specialty medications dominating.
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Last year, the Food and Drug Administration approved the highest number of new drugs since 1996.

And for the third consecutive year, specialty drugs dominated the list, with 22 of the 37 medications approved in 2012 being specialty medications.

Specialty drugs have represented an increasing percentage of FDA approvals as pharmaceutical manufacturers focus on discovering and developing drugs to treat chronic and complex diseases such as cancer, rheumatoid arthritis, hepatitis C and multiple sclerosis.

Oncology and Orphan Drugs

Considering less than 1% of the U.S. population uses specialty drugs, the overwhelming focus is noteworthy, with much of the development going toward new treatments for cancer and orphan conditions – rare conditions that currently have limited treatment options. Of the drugs approved last year, 10 are for the treatment of cancer, and 10 are orphan drugs.

Several of the new cancer drugs are oral formulations, which is also a growing trend in the pharmacy landscape. Because they are easier to take, oral cancer drugs can increase patient demand. This is expected to shift some cost from the medical benefit to the pharmacy benefit.

Orphan drugs tend to be among the costliest of specialty medications, typically more than $200,000 per year. Orphan drugs approved last year include treatments such as KalydecoTM (ivacaftor) for a rare form of cystic fibrosis and Signifor® for Cushing’s disease, caused by overproduction of the hormone cortisol.

One noteworthy drug approved last year is Xeljanz® – the first oral, targeted drug to treat rheumatoid arthritis – which will compete with injectable biologics such as Enbrel® and Humira®.

Traditional Blockbuster

While more of the development is trending toward specialty, the traditional market had some key approvals in 2012 as well – namely, two new weight-loss medications and a new anticoagulant. Because these drugs target a broader population, they have potential for a large impact.

Belviq® and QsymiaTM are two new weight-loss medications approved last year. Obesity affects nearly 1 in 3 Americans. Eliquis® is an anticoagulant to reduce the risk of stroke in patients with atrial fibrillation, the most common type of irregular heartbeat. This condition is estimated to affect about 5.8 million people in the U.S.

Watch for tomorrow's post about the drugs expected to gain FDA approval in 2013.



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