FDA approves Gilead’s hepatitis C remedy Harvoni (ledipasvir and sofosbuvir)
SILVER SPRING, Md. – The Food and Drug Administration on Friday approved Gilead's Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection, the agency stated. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and healthcare professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”
Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.
Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15% to 30% of these people will go on to develop cirrhosis.
Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor, if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Harvoni and Sovaldi are marketed by Gilead based in Foster City, Calif. Olysio is marketed by Janssen Pharmaceutical based in Raritan, N.J.
Cardinal Health helps launch $13 million molecular imaging facility
COLUMBUS, Ohio – The Ohio State University, Cardinal Health and State of Ohio Third Frontier Commission on Wednesday announced the completion of a five-year long project to create a new, $13 million molecular imaging pharmaceuticals center that aims to shape the future of the medical diagnostic industry.
The state-of-the-art, 27,000-square-foot facility — called the Translational Research Center for Molecular Imaging Pharmaceuticals at the Wright Center of Innovation in Biomedical Imaging — will combine Ohio State's Wright Center of Innovation in Biomedical Imaging's research capabilities with Cardinal Health's developmental, manufacturing and commercialization expertise for molecular imaging agents.
The facility will research and produce specialized pharmaceuticals called "imaging agents," which are injected into the body and seek out particular cellular functions that are indicative of specific disease processes. These imaging agents are visible using sophisticated imaging equipment, and help aid in both the diagnosis and treatment of diseases including cancer, cardiovascular and neurological disorders.
"This research center is another example of how effective private-public partnerships can be at creating investment and opportunity right here in Ohio," said Ohio Lt. Governor Mary Taylor. "Strong leadership from Cardinal Health and The Ohio State University, in collaboration with the State of Ohio, will not only create good-paying jobs, but also provide opportunities to conduct cutting-edge research leading to new breakthroughs in medical imaging, diagnostics and pharmaceuticals."
The facility is located on Ohio State's west campus, in close proximity to its Wexner Medical Center, Veterinary Medical Center, West Campus Technology and Incubator facilities — with the ultimate goal of ensuring the new facility is fully integrated into key infrastructure at the university.
"The competitively awarded Ohio Third Frontier funding has been the key enabler to transform Ohio's technology and innovation environment and bring us all together to synergize our collective teams, resources and potential to shape the future of Ohio's economy, precision health care and scientific discoveries," said Michael Knopp, principal investigator and director of the Wright Center.
The new center supports more than 80 employees, including Ohio State researchers and Cardinal Health radiopharmaceutical manufacturing and nuclear pharmacy operations personnel. In addition, an endowed faculty position as the Ohio Molecular Imaging Pharmaceutical Scholar — along with other researchers — have been added to the faculty and staff of Ohio State's Department of Radiology.
"We are very excited that this collaboration between Cardinal Health and Ohio State will advance medical imaging to more effectively alert patients to seek treatment for life-threatening diseases," said Ohio State president Michael Drake. "The university's research expertise paired with the development capacity of Cardinal Health will expedite the discovery and delivery of quality health care while promoting a critical industry in our region."
The new molecular imaging technology center will provide Ohio State researchers with unique manufacturing capabilities and expertise to aid in their research and creation of new molecular imaging agents in Positron Emission Tomography, also known as PET imaging. As new imaging pharmaceuticals move through the drug approval pipeline, Cardinal Health will also support their development, manufacturing and dispensing for clinical drug trials in Ohio and across its national network of radiopharmaceutical facilities.
"This public-private partnership positions central Ohio as a state-of-the-art location for the research, development, clinical investigational trials and full commercialization of new molecular imaging agents," said George Barrett, chairman and CEO of Cardinal Health. "By helping physicians diagnose disease at its earliest stages and evaluate the efficacy of treatment, these new imaging pharmaceuticals can save lives and help reduce the overall cost of health care."
Second annual tweet-a-thon proved how #Pharmacists can make a difference
Kicking off American Pharmacists Month this year on Oct. 2 was the second annual #Pharmacist tweet-a-thon. Highlighting the important role pharmacists play in patient care, their communities and the broader healthcare landscape, more than 11,000 tweets with the hashtag #Pharmacist were sent during the 24-hour period — some 467 an hour, according to healthcare social media watcher Symplur.
Last year, more than 7,100 tweets with the hashtag #Pharmacist were sent during the inaugural tweet-a-thon on Oct. 3, 2013. Year-over-year, that's a 55% increase in participation.
That's a lot of pharmacists touting about their noble profession. @Phowler (Lisa Schwartz) tweeted, "I want patients to ask me questions about medications — when to start, how to take and when to stop. Rx, OTC or supplements. #Pharmacist." "Do u spend a lot each month on meds? Talk to a #pharmacist now about less expensive alternatives! #helpmehelpyou," tweeted @joeymattingly (Joey). And @KurtProctor, (Kurt Proctor, SVP strategic initiatives at the National Community Pharmacists Association), tweeted, "Your #pharmacist is ready to help, no matter what is keeping you from taking your medications as prescribed."
Pharmacists are not only knowledgeable healthcare professionals who can provide counseling in the form of medication therapy management or disease state management; pharmacists are not only caring professionals who can help patients save money in an effort to boost adherence (and lower future healthcare costs); pharmacists are also there, conveniently located and easily accessible, or in other words "ready to help" as Proctor tweeted.
The value of the pharmacist is signficant, and patients are looking to tap into it. According to McKesson Patient Relationship Solutions' research released last week, an increasing number of patients do not fully understand their medical condition and are more interested in personal communications from their healthcare practitioners concerning their condition. And increasingly, that communication is coming from their neighborhood pharmacist. More than half (52%) of patients surveyed rely on their pharmacist for information about their medication, and an increasing number are seeking information about how to save on medicines from their pharmacist (34%).
Drug Store News director of continuing education and clinical content Suzanne Feeney, PharmD, even got in on the action by taking over the DSN Twitter handle @drugstorenews for the second annual #Pharmacist tweet-a-thon."A big thank you to all the #pharmacists out there for being committed to the health & safety of your patients every day!," she tweeted, after a very busy day of following the trending hashtag #pharmacist. Feeney featured a photo of her getting her annual flu shot, administered by her pharmacist at Jewel-Osco.
The now annual tweet-a-thon aims to spark awareness of the good that the pharmacy profession does on a daily basis. To help underscore that value of the pharmacist in today's healthcare paradigm, the American Pharmacists Association kicked off its campaign at the top of the month, called “Know Your Pharmacist — Know Your Medicine.” The more patients who know their pharmacists, the more they'll know about their medications — from documented successes to contraindications, according to the APhA.
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