PHARMACY

Taro makes Keveyis available to distributors for free

BY David Salazar
HAWTHORNE, N.Y. — Taro Pharmaceutical USA on Tuesday announced a plan to make its primary periodic paralysis drug Keveyis (dichlorphenamide) available to distributors at no cost. The company will stop commercial sales and promotional activities for the ultra-rare disease treatment.  
 
“We embarked on this decade-long journey to help a patient community in need and we are proud that it resulted in Keveyis, the first medicine approved for the treatment of periodic paralysis,” Taro USA CEO Kal Sundaram said. “Through heartfelt testimonials, patients have told us how their lives have changed for the better thanks to this treatment being available.”
 
Taro said that it had expected to only treat a few hundred patients with Keveyis, but that the company had difficulty reaching a small pool of people — of those estimated to have periodic paralysis, fewer than 1,500 are thought to be diagnosed, and among these lifestyle changes and off-label prescription medications are used to manage the illness. 
 
As a result, Keveyis has seen less than $1 million in sales, and the investment in marketing the drug has become unsustainable, the company said. The company said that many patients have an average out-of-pocket cost of less than $25 per month, and some have received the treatment for free through Taro’s support program and patient assistance program.
 
“This decision extends our desire to ensure that anyone with a prescription will continue to have access to the medicine regardless of insurance status or ability to pay,” Sundaram said. 
 
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Study: Moms who get flu shot while pregnant provide significant protection to newborn

BY Michael Johnsen
SALT LAKE CITY – Babies whose moms get flu vaccinations while pregnant have a significantly reduced risk of acquiring influenza during their first six months of life, a new study shows, leading the authors to declare that the need for getting more pregnant women immunized is a public health priority.
 
In a study published May 3, 2016, in Pediatrics online, University of Utah School of Medicine researchers reported that infants 6 months and younger whose mothers were vaccinated when pregnant had a 70% reduction in laboratory-confirmed flu cases and an 80% reduction in flu-related hospitalizations compared with babies whose moms weren't immunized. Health records showed that 97% of laboratory-confirmed flu cases occurred in infants whose mom's were not immunized against the disease while pregnant.
 
"Babies cannot be immunized during their first six months, so they must rely on others for protection from the flu during that time," stated Julie Shakib, assistant professor of pediatrics and lead author. "When pregnant women get the flu vaccine there are clear benefits for their infants."
 
Maternal-fetal medicine specialist Michael Varner, professor and vice chair for research in the Department of Obstetrics and Gynecology and a co-author on the study, says pregnant women are not at greater risk for getting the flu, but because of changes that occur to their bodies during pregnancy, are more likely to be severely affected.
 
Shakib and colleagues examined more than 245,000 de-identified health records of pregnant women and more than 249,000 infant records for nine flu seasons from December 2005 through March 2014. (The number of infant births included twins, triplets or even larger sets of babies, which accounts for the total number of infant birth records being greater than the number of records of pregnant women.) Approximately 10% of the women – 23,383 – reported being vaccinated while pregnant compared with 222,003 who said they were not vaccinated.
 
The difference between the two groups in the number of laboratory-confirmed influenza cases and influenza hospitalizations within six months of birth was stark, the researchers found. Among 658 infants identified with laboratory-confirmed influenza, 638 cases – 97% – occurred in babies whose moms were not immunized. A total of 151 of the 658 infants were hospitalized, with 148 being born to non-immunized pregnant women.
 
In order to confirm that the benefits observed in infants born to mothers who received flu vaccinations were not related to chance, the researchers also examined health records for the incidence of respiratory syncytial virus, a respiratory infection that also occurs in infants and young children during the winter months. The analysis found that the vaccine had no effect on the incidence of RSV among infants, strengthening the findings that the benefits seen in the infants were actually due to the flu vaccine their mothers received.
 
Although the vaccination rate among pregnant women has increased since the H1N1 pandemic, it's still not high enough, according to infectious diseases expert Carrie Byington, senior author on the study, professor of pediatrics and co-director of the Center for Clinical and Translational Science at the University of Utah Health Sciences, which provided support for the study.
 
"This is a public health issue," Byington said. "About 50% of pregnant women reported being immunized in the latest flu season. But we need to get that number much closer to 100%."
 
Vaccination rates in pregnant women averaged 10% over the course of the nine flue seasons studied. However, between June 2009 and September 2010, when the spread of the H1N1 flu reached pandemic levels worldwide, vaccination rates increased significantly as people became more aware of the risks of flu for pregnant women and their infants. "Pregnant women are a high-risk group during influenza season and influenza outbreaks and should receive vaccinations," Varner said. "If their caregivers don't offer them influenza vaccinations, I would encourage all pregnant women to ask them for it."
 
"We just really hope more pregnant women get the vaccine," Shakib added. "That's the take-home message of the study."
 
 
 
 
 
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FDA approves first drug for Parkinson’s-related hallucinations, delusions

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration recently approved a new drug that treats delusions and hallucinations that are associated with psychosis affecting patients with Parkinson’s disease. 
 
Nuplazid (pimavanserin), from Acadia Pharmaceuticals, is the first medication to be approved to treat Parkinson’s-related psychosis, which affects some 40% of the 4-6 million patients with Parkinson’s disease. The drug was granted breakthrough therapy designation and a priority review by the FDA. 
 
“Hallucinations and delusions can be profoundly disturbing and disabling,” said Dr. Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”
 
Acadia expects Nuplazid to be available in June.
 
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