FDA Approves New Cystic Fibrosis Treatment
Via CNBC
The U.S. Food and Drug Administration said Thursday it had approved the use of Vertex Pharmaceuticals’ Orkambi, a drug aimed to treat patients with cystic fibrosis, on patients who are at least 12 years old.
The company’s shares were temporarily halted, up 3.73 percent at $130.90, during late-morning trading for pending news ahead of the announcement at 11:47 a.m. ET. Trading started again around 3 p.m. ET, and Vertex closed the day slightly higher than its halt price.
“…The approval of ORKAMBI represents a fundamental change in the treatment of the most common form of CF, marking significant progress for us and for the entire CF community,” Dr. Jeffrey Leiden, Vertex’s chairman, president and CEO, said in a statement.
With the approval, Orkambi will be available to about 8,500 patients in the United States, according to Reuters.
Cystic fibrosis is caused by a defective gene that disrupts the function of the lungs and digestive system, producing a build-up of thick, sticky mucus leading to inflammation and recurrent bacterial infections..
Kalydeco Health Concerns
Some health concerns if your child is taking Kalydeco. Read more. Click here: http://www.fda.gov/Drugs/DrugSafety/ucm316693.htm Please check back or email us with any questions. info@roadmaptocf.org
Hepatitis C investigation at The University of Michigan
UMHS one of six Michigan facilities linked to New Hampshire hepatitis C investigation
The Michigan Department of Community Health has been investigating the employment history of a Hepatitis C-positive health care worker who was recently arrested in New Hampshire for allegedly obtaining injectable narcotics at hospitals there, and infecting patients with the Hepatitis C virus through used syringes. To read more please click below:
Keeping healthy with cystic fibrosis
Check out all the stories about fabulous people staying healthy with cystic fibrosis.
http://www.everydayhealth.com/mens-health/outrunning-cystic-fibrosis.aspx
Affordable Care Act supports families who have children with CF
Affordable Care Act supports families of children with special health care needs
Health and Human Services (HHS) Secretary Kathleen Sebelius today announced $4.9 million in Affordable Care Act funding to support Family-to-Family Health Information Centers, primarily non-profit organizations run by and for families with children with special health care needs.
“These centers provide the information that families need to make health care decisions that are right for their children,” Secretary Sebelius said. “Family-to-Family Health Information Centers are a good investment, and have a measurable and positive impact on families, and communities.”
Vertex brings hope
Parents who have kids with the deltaF508 strain of cystic fibrosis will soon be able to breathe a little easier.
Results from the clinical trials by Vertex Pharmaceutical’s have stocks climbing. The drug company climbed 55 percent to $58.12 at the close of the New York trading on May 7th, 2012.
Click here to read the full article
Kalydeco: A Homerun For CF
The FDA has approved KalydecoTM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. Kalydeco is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Approximatel 1,200 people in the United States, or 4% of those with CF, are believed to have this mutation.
Kalydeco was granted approval in approximately 3 months, making it one of the fastest FDA approvals ever and marking the second approval of a new medicine from Vertex in less than a year.
