The U.S. Food and Drug Administration on Thursday approved the drug Elevidys, the first gene therapy for the treatment of children with Duchenne muscular dystrophy (DMD). The groundbreaking treatment will not be cheap: Drugmaker Sarepta Therapeutics Inc. said it would charge $3.2 million for the one-time IV treatment, the Associated Press reported. Like most medicines in the United States, the cost would be mostly paid by insurers. The drug will be used to treat children ages 4 through 5 who have a mutation in the DMD gene. “Today’s approval addresses an urgent unmet medical need and is an important advancement in the treatment of Duchenne muscular dystrophy, a devastating condition with limited treatment options, that leads to a progressive deterioration of an individual’s health over time,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release. “The approval of Elevidys is a watershed moment for the treatment of Duchenne. Elevidys is the first and only gene therapy approved for Duchenne, and this approval brings us closer to our goal of bringing forward a treatment that provides the potential to alter the trajectory of this degenerative disease,” Sarepta President and CEO Doug Ingram said in a company statement. Advocates welcomed the approval. “Today’s decision marks an important moment in gene therapy for patients living with Duchenne,” said…  read on >  read on >

(HealthDay News) – Americans could soon be eating “lab-grown” chicken at upscale restaurants after the U.S. Department of Agriculture approved products made by two companies on Wednesday. Upside Foods and Good Meat, both based in California, will be the first in the United States to sell meat that’s cultivated in a laboratory rather than from slaughtered animals. The meat is still actually meat, coming from animal cells, fertilized eggs or stored cells. “Instead of all of that land and all of that water that’s used to feed all of these animals that are slaughtered, we can do it in a different way,” Josh Tetrick, co-founder and chief executive of Eat Just, which operates Good Meat, told the Associated Press. The U.S. Food and Drug Administration had already determined the products were safe to eat, the AP reported. Manufacturing company Joinn Biologics was given the go-ahead to make products, which will initially be sold at the restaurant Bar Crenn in San Francisco in the case of Upside products, and at restaurant in Washington, D.C., run by chef Jose Andrés in the case of Good Meat. Singapore was the first country to begin allowing cultivated meat, the AP reported. The meat is grown in steel tanks, coming out in large sheets and then cut into expected shapes. The Upside chicken looks slightly paler, but has the same…  read on >  read on >

Consuming omega-3 fatty acids like flaxseed oil and walnuts may help slow the decline in physical function related to amyotrophic lateral sclerosis (ALS), new research suggests. ALS (formerly known as Lou Gehrig’s disease) is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. People with ALS lose the ability to initiate and control muscle movement over time. The average life span after diagnosis is two to five years. A slower decline in symptoms may also slightly extend survival for people with ALS, the researchers noted. The new study findings were published online June 21 in the journal Neurology. “The link our study found between diet and ALS is intriguing and suggests, but does not prove, that people with ALS may benefit from incorporating more omega-3 fatty acids into their diet,” said Dr. Kjetil Bjornevik, an assistant professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health, in Boston. “It will now be important to conduct additional research looking specifically at the plant-based omega-3 fatty acid alpha-linolenic acid in people with ALS to further explore this possibility,” Bjornevik said in a journal news release. Besides flaxseed oil and walnuts, good sources of omega-3 fatty acids include canola oil and pumpkin seeds. Consuming more omega-6 fatty acid could also be beneficial, the investigators found. To study the link between…  read on >  read on >

The U.S. Food and Drug Administration on Tuesday approved two drugs that have been used in adults with type 2 diabetes for years for use in children aged 10 and up. The approvals of Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) provide a new class of medications for pediatric type 2 diabetes. They join metformin, which has been approved for children with type 2 diabetes since 2000. “Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” Dr. Michelle Carey, associate director for therapeutic review for the division of diabetes, lipid disorders and obesity in the FDA’s Center for Drug Evaluation and Research, said in an agency news release. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.” Type 2 diabetes is a chronic, progressive condition in which the body does not make or use insulin normally. Type 2 diabetes in children increased by 4.8% per year from 2002 to 2015, according to the SEARCH for Diabetes in Youth study. That number could reach 220,000 by 2060 if trends continue. The majority of cases are occurring in minority racial and ethnic groups. Before the approval, the active ingredient in both medications was tested for safety and effectiveness in a double-blind, randomized trial that included 157…  read on >  read on >

You could have high blood pressure and not realize it. The only way to know for sure is to have your blood pressure tested. It’s an important step, according to the American Heart Association (AHA), and so is understanding your results so you can keep your blood pressure under control. A diagnosis of high blood pressure — and any unusually low blood pressure readings – must be made by a health care professional. Blood pressure readings have two numbers. Systolic blood pressure is the upper number and tells you how much pressure your blood is exerting against your artery walls when the heart contracts. The diastolic blood pressure is the lower number and it reveals the pressure your blood is exerting against your artery walls while the heart muscle rests between its contractions, the AHA said. Although either number can be used to diagnose high blood pressure, the systolic blood pressure is more notable and can be a major risk factor for cardiovascular disease for people over 50. That number typically rises steadily with age because large arteries stiffen and there is long-term buildup of plaque and an increased incidence of cardiac and vascular disease, the AHA said. Here are the five blood pressure ranges: American Heart Association The five blood pressure ranges are normal, elevated, hypertension stage 1, hypertension stage 2 and hypertensive crisis.…  read on >  read on >

An advisory panel to the U.S. Food and Drug Administration voted unanimously on Thursday to recommend that COVID booster shots be updated for the fall to protect solely against one of the three XBB variants that have taken hold in the United States. Those three XBB variants, which are all sublineages of the Omicron variant, are XBB.1.5, XBB.1.16 and XBB.2.3, CNN reported. What will be dropped from the updated vaccines will be protection against the original strain of the virus because experts believe it could contribute to lower vaccine efficacy against newer strains. “Your immune response likes to react to what it’s seen before,” Dr. David Ho, a professor of microbiology and immunology at Columbia University whose research was cited in FDA briefing documents, told CNN. “That’s why we made the recommendation that if you want to broaden out your antibody responses, it’s best to remove the ancestral spike in future vaccines,” Ho explained. Although the FDA will make the final decision on the updated vaccines, it typically follows the advice of its advisory panels. While infections have declined across the United States, the virus could be a concern next winter, the FDA’s vaccine chief Dr. Peter Marks said as the daylong meeting began, the Associated Press reported. “We’re concerned that we may have another wave of COVID-19 during a time when the virus has…  read on >  read on >

While food allergies have not historically been top of mind for racial and ethnic minorities, new research shows that Hispanic, Black and Asian communities all face a higher prevalence of these issues. Money also mattered: In households where incomes were higher, at more than $150,000 a year, food allergies were less prevalent. “Food allergies are not frequently talked about impacting racial and ethnic communities,” said study co-author Dr. Ruchi Gupta, director of the Center for Food Allergy and Asthma Research and a professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago. “It’s not on the radar. But we now know it does impact them more, and it’s important to improve awareness.” “It is also critical to improve access to diagnosis and treatments for food allergy,” Gupta said in a university news release. “It is an exciting time with new treatments, and it’s essential to make sure they reach racial and ethnic minorities who have higher rates of food allergy.” For the study, the researchers administered a survey online and via telephone to a nationally representative sample of the U.S. population, including more than 50,000 households with responses for nearly 80,000 individuals. The survey was given from October 2015 to September 2016. Food allergy affects 11% of adults and 8% of children in the United States. The study found that prevalence of food…  read on >  read on >