This Revolutionary FDA Approval Showcases an Important Trend

Dignitana DigniCap Cooling Cap Set. Image source: Dignitana.

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Earlier this month, we witnessed history. For the first time, the Food and Drug Administration approved the marketing of a cooling cap to be used on female patients undergoing chemotherapy treatment for breast cancer.

The cooling cap, known as the Dignitana DigniCap Cooling System, is designed to reduce the severity of hair loss for people undergoing chemotherapy. With the assistance of a computer, cooled liquid is pumped through a head-worn cap, thereby constricting blood vessels in the scalp and preventing the chemotherapy drugs from reaching the hair follicles. Some breast cancer patients have been known to refuse chemotherapy for fear of having to deal with the resulting hair loss (known as alopecia), so there's hope the Dignitana DigniCap Cooling System will improve patient confidence and allow potentially life-saving and quality-of-life-improving treatments to reach these patients.

For the time being, the Dignitana DigniCap Cooling System will only be approved for female breast cancer patients, but expanded use is on the table. Among the 122 women with stage 1 and 2 breast cancer who were treated with the cooling cap, more than 66% reported losing less than half of their hair.

The cooling cap may not be as revolutionary as, say, cancer immunotherapies, which have the potential to boost patients' immune systems so that they can better locate and destroy cancer cells, but it highlights a growing trend among drug developers: a push toward improving quality of life. Not only are we seeing new therapies emerge across many therapeutic indications, but we're also seeing dramatically reduced side effects associated with new therapies.

Quality-of-life improvements abound Perhaps the best example of this can be seen in the recent advancements in the treatment of hepatitis C, a virus that can result in fibrosis of the liver or even liver cancer, liver failure, or death.

Image source: Gilead Sciences.

In early 2011, the standard of care for hepatitis C was for patients to receive interferon infusions and ribavirin for up to 48 weeks. This combination produced an effective cure rate of around 50%, but many patients had to deal with flu-like symptoms, anemia, and rashes, to name a handful of the nasty side effects. The introduction of Incivek in 2011 improved the efficacy rate substantially (to nearly 80%) in clinical studies, but it didn't do much to alleviate the side effects, as interferon and ribavirin were still needed. However, the FDA approvals of Gilead Sciences' drugs Sovaldi and Harvoni in 2013 and 2014, respectively, changed everything.

Harvoni has been an especially revolutionary treatment for HCV genotype 1 patients. This once-daily pill has reduced treatment durations to as little as eight weeks for treatment-nave, non-cirrhotic HCV-1 patients, with the typical treatment lasting 12 weeks. Even more importantly, Gilead's dynamic duo has improved the effective cure rate to 90%-plus in many instances. And the icing on the cake is that Harvoni doesn't need to be administered in conjunction with interferon or ribavirin.

A new once-daily HCV treatment in Gilead's pipeline, a cocktail drug containing Sovaldi and velpatasvir, cured 98% of trial participants across all six HCV genotypes. This pan-genomic treatment, if approved, demonstrates how far we've come in a relatively short period.

A big leap forward in type 2 diabetes care Another good example of treatments that are improving quality of life are SGLT2 inhibitors for type 2 diabetes. One of the more commonly prescribed treatments for type 2 diabetes, or T2D, are DPP4 inhibitors. Pretty much all medications to treat glycemic imbalances work through the pancreas and/or liver. SGLT2 inhibitors don't. Instead, they inhibit the absorption of glucose in the kidneys, allowing the patients to excrete excess glucose through their urine.

Image source: Boehringer Ingelheim.

What makes SGLT2 inhibitors so unique is that in addition to offering T2D patients another option for controlling their high blood sugar, they have also demonstrated a number of positive "side effects" in trials. Most notably, SGLT2 inhibitors have been shown to induce weight loss and lower systolic blood pressure. To be clear, this doesn't mean SGLT2 inhibitors are being prescribed as weight-loss drugs, nor to control high blood pressure. However, because type 2 diabetics tend to be overweight and/or have high blood pressure, SGLT2 inhibitors may provide some welcome assistance.

One SGLT2 inhibitor that's been a real standout and demonstrates just how far we've come in terms of improving patient quality of life is Jardiance, developed by Eli Lilly and Boehringer Ingelheim. Eli Lilly and Boehringer reported this summer that the long-term cardiovascular trial for Jardiance, known as EMPA-REG OUTCOME, demonstrated a statistically significant reduced risk of death, non-fatal heart attack, and non-fatal stroke for type 2 diabetics taking Jardiance compared to a placebo (which, by the way, is incredible!). What's even more exciting is that there are well over 200,000 ongoing clinical studies, according to, meaning potentially groundbreaking medicines could soon be a reality. It's an exciting time to be an investor, but it's even more fulfilling to watch the advances being made in treating chronic, rare, and potentially deadly diseases. I can only hope 2016 and every year after brings many more discoveries of not merely more-effective medicines, but medicines that improvepatients' quality of life.

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Sean Williamshas no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen nameTMFUltraLong, track every pick he makes under the screen nameTrackUltraLong, and check him out on Twitter, where he goes by the handle@TMFUltraLong.The Motley Fool owns shares of and recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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