FLINT, Mich., Oct. 22, 2014 /PRNewswire/ -- U.S. Food and Drug Administration (FDA) announced October 10, 2014 that Gilead Sciences Harvoni® (ledipasvir/sofosbuvir) product was approved for the treatment of chronic hepatitis C, genotype 1 infection in adults. Harvoni® is the first oral combination therapy approved for the treatment of hepatitis C and is also the first treatment regimen that does not require administration with pegylated interferon or ribavirin.
Harvoni® is a once-daily, fixed-dose tablet that combines 90 mg of the NS5A inhibitor ledipasvir with 400 mg of the nucleotide analog polymerase inhibitor sofosbuvir. Sofosbuvir was approved by the FDA under the trade name Sovaldi® in December 2013. The duration of treatment with Harvoni® is eight, 12 or 24 weeks, depending on the patient's prior treatment history, cirrhosis status and baseline viral load. Harvoni's® efficacy has been established in patients with chronic hepatitis C in three Phase 3 studies: ION-1, ION-2 and ION-3.
Hepatitis C is a viral disease that causes inflammation of the liver, which can lead to diminished liver function or liver failure. Some individuals with chronic hepatitis C infection may develop cirrhosis, in which liver tissue is replaced by scar tissue, eventually preventing the liver from functioning properly. According to the Centers for Disease Control and Prevention, approximately 3.2 million Americans are infected with hepatitis C. Unlike other serious or chronic diseases, hepatitis C can be cured with treatment.
Harvoni® was granted priority review and breakthrough therapy designation by the FDA as a medicine with the potential to offer major advances in treatment over available therapies. Harvoni® is a product of Gilead Sciences, based in Foster City, California. Harvoni will be broadly distributed at pharmacies throughout the country and will be continually stocked at Diplomat. For full prescribing information, please visit the manufacturer's website: http://www.gilead.com/medicines.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including relating to Diplomat's distribution of the drug set forth above (and any implied financial impact). The forward-looking statements contained in this press release are based on management's good-faith belief and reasonable judgment based on current information, and these statements are qualified by important risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from those forecasted or indicated by such forward-looking statements. These risks include the number of patients prescribed such drug currently and in the future, patient's adherence to such drug, the number of distributors on panel and our relative distribution share, the timing of drug sales, the cost of such drug and reimbursement rates by payors, drug competition, and the factors set forth in "Risk Factors" in Diplomat's prospectus dated October 10, 2014 and in subsequent reports filed with or furnished to the Securities and Exchange Commission. Except as may be required by any applicable laws , Diplomat assumes no obligation to publicly update such forward-looking statements, which are made as of the date hereof or the earlier date specified herein, whether as a result of new information, future developments or otherwise.
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Diplomat (NYSE: DPLO) serves patients and physicians in all 50 states. Headquartered in Flint, Michigan, the company focuses on medication management programs for people with complex chronic diseases, including oncology, immunology, hepatitis, multiple sclerosis, HIV, specialized infusion therapy and many other serious or long-term conditions. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: "Take good care of patients, and the rest falls into place." Today, that tradition continues – always focused on improving patient care and clinical adherence. For more information visit www.diplomat.is. Follow us on Twitter and LinkedIn and like us on Facebook.
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