10 Drugs Approved by the FDA in 2012 to Be Thankful For

In the theme of Christmas and the spirit of giving, I plan to use the next two weeks leading up to Christmas to countdown the 12 Days of Christmas in all its Foolish glory. In my rendition of this Christmas tale, you won't be hearing about turtle doves or French hens, but you'll probably hear about great ways to save money in 2013 or about CEOs who laid rotten eggs in 2012.

In the previous "Foolish Days of Christmas" we've looked at:

As always, I ask you to sing along with me... "On the 10th day of Christmas my true love gave to me..."

10 drugs approved by the FDA in 2012 to be thankful for!

In total, the Food and Drug Administration approved 35 new drugs in 2012. Here are 10 key approvals in 2012 that could shape the health-care landscape moving forward.

1. Xtandi by Medivation (NASDAQ: MDVN  )
Perhaps one of the most pleasant surprises this year was the approval of Xtandi for metastatic castration-resistant prostate cancer three months before its scheduled PDUFA date. As my Foolish colleague Brian Orelli noted, that's not something you see every day. Xtandi extended median survival time versus the placebo by nearly five months and gives patients an alternative to chemotherapy. 

2. Stribild by Gilead Sciences (NASDAQ: GILD  )
Stribild, a four-in-one once-daily pill to treat HIV, is one of Gilead's primary growth drivers going forward. Meant to replace previous HIV treatments Atripla and Complera, which contain drugs from Bristol-Myers Squibb (NYSE: BMY  ) and Johnson & Johnson (NYSE: JNJ  ) , Stribild uses two already approved FDA compounds and two new compounds. The result is better margins for Gilead and ultimately better treatment options for HIV patients.

3. Belviq by Arena Pharmaceuticals (NASDAQ: ARNA  )
Although Belviq is awaiting its final classification by the DEA, it looks to be on a prime path to claim the lion's share of the chronic weight management market. Since receiving FDA approval over the summer, insurer Aetna (NYSE: AET  ) has stepped forward and announced it'll support coverage for the weight-loss drug once it reaches pharmacy shelves. It's probably just a matter of time before other insurers are on board as well.

4. Qsymia by VIVUS (NASDAQ: VVUS  )
I may "pooh-pooh" Qsymia in comparison to Belviq, but there's still enough room in the weight control management space for two drugs. Qsymia did demonstrate higher weight-loss efficacy in trials relative to Belviq, and while it won't be receiving approval in Europe any time soon, it did beat Belviq to market and has a chance to "get its feet wet" before Belviq hits pharmacy shelves.

5. Kyprolis by Onyx Pharmaceuticals (UNKNOWN: ONXX.DL  )
Onyx Pharmaceuticals' relapsed and refractory multiple myeloma drug looked like anything but a sure shot heading into its FDA panel meeting considering potential heart, liver, and lung concerns. Following that meeting, Kyprolis was smelling like a rose. Kyprolis eliminated or reduced the target cancer in 23% of the tested patients and will slide in as a tertiary treatment for those who have tried at least two other multiple myeloma therapies. 

6. Omontys by Affymax (NASDAQ: AFFX  )
Omontys was approved in late March as a once-a-month injectable treatment for anemia for patients on dialysis. Omontys has clear convenience factor benefits over Amgen's (NASDAQ: AMGN  ) Epogen, but the battle to secure sales won't be easy with Amgen having long-term contracts already in place with dialysis centers around the United States. Still, with a drug finally on the market, Affymax shareholders have something to cheer about.

7. Linzess by Ironwood Pharmaceuticals (NASDAQ: IRWD  ) & Forest Labs (NYSE: FRX  )
Another drug that managed to sneak its way onto pharmacy shelves before its PDUFA date was irritable bowel syndrome and constipation, or IBS-C, pill Linzess. According to the FDA, 15.3 million people are affected by IBS, and roughly 63 million people by chronic constipation, so while there is no cure-all for both problems, Linzess will give some suffers a way to lessen their abdominal discomfort and increase the ability to make complete bowel movements.

8. Bosulif by Pfizer (NYSE: PFE  )
Rare diseases are garnering big attention these days, and Pfizer's approval for Bosulif to treat one of the four variations of chronic myeloid leukemia is evidence to the commitment of big pharma to help tackle these diseases. In trials, Bosulif returned blood counts to a normal range in 55% of patients within 48 weeks while delivering a complete hematological response in 33% of patients who had previously taken and had become unresponsive to Gleevec

9. Amyvid by Eli Lilly (NYSE: LLY  )
As Foolish health-care guru Brian Orelli put it, Amyvid is merely a process-of-elimination test that's used to help physicians diagnose whether a patient has the plaque markers often associated as a precursor to Alzheimer's pathology. The beta-amyloid plaque-detecting drug empowers physicians in a way that only autopsies had previously done. Don't be surprised if Alzheimer's research becomes the next big thing in the health-care sector. 

10. Eylea by Regeneron Pharmaceuticals (NASDAQ: REGN  )
Last, but certainly not least, we have Eylea from Regeneron Pharmaceuticals, which was actually first approved by the FDA in 2011 and has boosted sales forecasts dramatically three times in 2012. The reason I've chosen to include it here is the additional indication added in September for Eylea to treat wet age-related macular degeneration. According to Regeneron, this ailment affects 100,000 people in the U.S. and further strengthens its grip on eye-related ailments.

Editor's note: A previous version of this article incorrectly stated that Gleevec and Bosulif were tested head to head in a clinical trial. The Fool regrets the error.


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