The Food and Drug Administration gave preliminary approval to a second drug for a form of muscular dystrophy, a surprise decision after the medication — Vyondys 53 — was rejected just four months ago over concerns about the infections and kidney injury in animal studies.
The drug is for a specific type of muscular dystrophy that affects about 8% of boys with Duchenne’s. The drug will cost $300,000 per year for the typical patient — a child weighing 44 pounds, the company said. Sarepta Therapeutics said the FDA reversed its decision after it resubmitted its application. Preliminary results showed the drug boosts a protein that aids the growth of muscle fibers. But the drug has not been shown to improve mobility or health. The FDA is requiring followup studies.
C-section not tied to obesity in children
Some reports have suggested that women who give birth by cesarean section are more likely to have obese children. But a large new study found no link between the method of birth and obesity.
Swedish researchers tracked medical records of 97,291 men born between 1982 and 1987. An initial assessment found that there was a 4.9% rate of obesity for vaginal delivery, compared with 5.5% for elective C-section and 5.6% for nonelective C-section. But women who delivered by C-section were on average older, with a higher body mass index. They also tended to smoke more, were more likely to have pre-pregnancy diabetes and high blood pressure. When the researchers controlled for these and other factors, they found no link between mode of birth and obesity at age 18.