FDA Approves Expanded Indications for Gilead Sciences, Inc. (GILD) Harvoni and Sovaldi


Gilead Sciences, Inc. (NASDAQ:GILD) announced that the FDA has approved supplemental indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi® (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg. Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. There are an estimated 23,000-46,000 pediatric HCV patients in the United States, most of whom were infected with the virus at birth.

“The approvals of Sovaldi and Harvoni for pediatric patients will enable adolescents to finally benefit from interferon-free treatment for HCV infection,” said Karen Murray, M.D., professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s. “These therapies address a significant unmet medical need and represent an important advance for HCV-infected adolescents.”

“Gilead’s goal is to develop and deliver treatments that provide all patients with HCV the potential to be cured,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “For the first time, children 12 and older in the United States with genotypes 1 through 6 chronic HCV infection now have options of two direct-acting antiviral regimens that offer high cure rates while eliminating the need for interferon injections.”

Harvoni and Sovaldi each have a boxed warning in their respective product labels regarding the risk of hepatitis B virus reactivation in HCV/HBV co-infected patients. See below for important safety information.

Harvoni for Pediatric Patients

The supplemental new drug application (sNDA) approval is supported by data from an open-label clinical trial (Study 1116), which evaluated 12 weeks of treatment with Harvoni once-daily in genotype 1 treatment-naïve and treatment-experienced HCV-infected adolescents 12 years of age and older without cirrhosis or with compensated cirrhosis. The SVR12 rate was 98 percent overall (98/100). No subject experienced on-treatment virologic failure or relapse. Two subjects were lost to follow-up.

Adverse events were consistent with those observed in clinical studies of Harvoni in adults. The most common adverse reactions (≥10 percent, all grades) observed with treatment with Harvoni in HCV-infected pediatric patients were fatigue, headache and asthenia.

Sovaldi for Pediatric Patients

The sNDA approval is supported by data from an open-label clinical trial (Study 1112), which evaluated 12 or 24 weeks of treatment with Sovaldi and weight-based ribavirin in adolescents 12 years of age and older with HCV genotype 2 or 3. The SVR12 rate was 100% (13/13) in genotype 2 patients and 97% (36/37) in genotype 3 patients. No subject experienced on-treatment virologic failure or relapse. One patient was lost to follow up.

Adverse events were consistent with those observed in clinical studies of Sovaldi in adults. The most common adverse reactions (≥15 percent, all grades) observed with treatment with Sovaldi and ribavirin for 12 or 24 weeks in HCV-infected pediatric patients were fatigue, headache and nausea.

Shares of Gilead Sciences are currently trading at $66.60, up $0.11 or 0.17%. GILD has a 1-year high of $103.10 and a 1-year low of $65.38. The stock’s 50-day moving average is $68.60 and its 200-day moving average is $72.74.

On the ratings front, GILD has been the subject of a number of recent research reports. In a report released yesterday, Jefferies analyst Brian Abrahams reiterated a Buy rating on the stock, with a price target of $82, which represents a potential upside of 23% from where the stock is currently trading. On April 3, Credit Suisse’s Alethia Young maintained a Buy rating on GILD and has a price target of $79.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Abrahams and Alethia Young have a yearly average return of 7.7% and a loss of 0.5% respectively. Abrahams has a success rate of 52% and is ranked #496 out of 4556 analysts, while Young has a success rate of 42% and is ranked #3446.

Sentiment on the street is mostly bullish on GILD stock. Out of 18 analysts who cover the stock, 12 suggest a Buy rating and 6 recommend to Hold the stock. The 12-month average price target assigned to the stock is $82.57, which represents a potential upside of 24% from where the stock is currently trading.

Gilead Sciences, Inc. is a biopharmaceutical company, which discovers, develops and commercializes therapeutics for unmet medical need. It focuses on human immunodeficiency virus and liver diseases, such as chronic hepatitis C virus infection & chronic hepatitis B virus infection, hematology & oncology, and cardiovascular & inflammation as well as respiratory diseases. The company’s products include Descovy, Odefsey, Genvoya, Stribild, Complera, Atripla, Truvada, Viread, Emtriva, Tybost, Vitekta, Vemlidy, Epclusa, Harvoni, Sovaldi, Viread, Hepsera, Zydelig, Letairis, Ranexa, Lexiscan, Cayston, Tamiflu, AmBisome and Macugen. 

 

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