06/01/2017
*2016 Year in Review.*
*Some Important Advances in Medicine.*
1. *Teixobactin – The First New Antibiotic in 30 Years Brings Hope Against Antibacterial Resistance*
2016 saw the breakthrough discovery of the resistance-fighting antibiotic teixobactin from soil bacteria. This first-in-its-class antibiotic has activity against Gram-positive organisms including MRSA and all mycobacteria, and a novel mode of action inhibiting peptidoglycan biosynthesis. Thanks to its quick bactericidal action and inhibition of cell-wall synthesis, it prevents the development of antimicrobial resistance. The drug is yet to be tested on humans.
2. *The World's First Artificial Pancreas*
Another one of the most exciting advances of 2016 was the FDA's approval of Medtronic's MiniMed 670G, a hybrid closed-loop insulin delivery system - the first device that automatically monitors blood glucose and administers appropriate basal insulin doses. This “Artificial Pancreas” is approved for patients aged 14 years and older with type 1 diabetes. This setup could dramatically reduce instances of hypoglycemia and greatly improve the quality of life of diabetics, who no longer have to constantly check their blood sugar throughout the day.
3. *Nobel Prize in Medicine Goes to Yoshinori Ohsumi for his Work on Autophagy*
Yoshinori Ohsumi of Japan won the 2016 Nobel Prize in Medicine and Physiology for his discoveries of mechanisms for autophagy. Disruptions in autophagy have been linked to cancer as well as disorders such as Parkinson's disease and type 2 diabetes. Dr. Ohsumi's research pointed to possible therapies for these conditions by identifying the genes that code for autophagy. This knowledge gives researchers clues on how to manipulate the process through drugs and gene therapy.
4. *Exondys 51 Brings Hope to Duchenne Muscular Dystrophy Patients*
Select sufferers of Duchenne muscular dystrophy (DMD) also got great news in 2016. In September, the FDA approved Exondys 51, a therapy designed to treat exon 51-skipping DMD, which affects about 1 in 8 DMD patients. This is the first drug ever approved by the FDA to treat DMD.
5. *FDA Bans Powdered Gloves*
The FDA issued a final rule banning powdered medical gloves beginning on 19 January 2017. The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove. It does not apply to not apply to powdered radiographic protection gloves. Non-powdered surgeon gloves and non-powdered patient examination gloves will also not be included in the ban and will remain Class I medical devices.
6. *The World’s First Malaria Vaccine Set for Rollout*
The Vaccine, known as RTS,S, acts globally against the deadly malaria parasite P. falciparum. Based on the results from clinical trials, the new vaccine will provide partial protection against malaria in young children. It will be given in four doses, and will be particularly efficient in preventing complications. Having secured funding, the vaccine is set to begin pilot studies in Africa.
7. *A pan-genotypic Hepatitis C Drug approval*
In June a unique HCV drug, Epclusa, was approved. However, Epclusa isn't your typical genotype-specific drug. Epclusa is the first pan-genotypic-approved drug, meaning it's capable of treating all six genotypes of hepatitis. It led to 95% to 99% virologic clearance 12 weeks after finishing treatment for patients with no or mild cirrhosis of the liver, while for those with moderate to severe cirrhosis, Epclusa in combination with a ribavirin led to 94% virologic clearance at the 12-week post-treatment mark.
8. *New Statin Guidelines*
The United States Preventive Services Task Force (USPSTF) updated its statin guidance in November. It gave a primary prevention recommendation based on strong evidence that:
All adults over the age of 40 with a 10-year CVD risk of more than 10 percent be offered statins at a low to moderate dose if they have one or more of dyslipidemia, diabetes, hypertension, or if they smoke.
If the 10-year risk was lower - between 7.5 percent and 10 percent - and there was at least one of these risk factors, the recommendation that the statin regime be offered was not as strong.
There was insufficient evidence to include any statin recommendation for adults aged 76 years and older.
9. *Limit Fluoroquinolone Use in the Light of Risks, FDA Says*
Patients with uncomplicated infections should no longer receive fluoroquinolones, given the risk for disabling and potentially permanent adverse events, the FDA said in May. Labels for these antibiotics already warn about the risks for tendonitis, tendon rupture, central nervous system effects, peripheral neuropathy, myasthenia gravis exacerbation, QT prolongation and torsades de pointes, phototoxicity, and hypersensitivity. The FDA has updated the labels to state that the serious risks posed by fluoroquinolones generally outweigh their benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections that are treatable by other means.
10. *Empagliflozin Wins Approval for Cardiovascular Disease Prevention*
This December, FDA approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. In approving the new indication, the FDA pointed out that cardiovascular disease is 70% higher in adults with diabetes and is often the cause of premature death for people with the condition. In an outcomes trial, Jardiance showed that it could cut the risk of cardiovascular death by 38%.
