Washington state told to lift restrictions on hepatitis C medicines

Washington state told to lift restrictions on hepatitis C medicines



The Washington state Medicaid program has been ordered to lift restrictions on coverage of pricey hepatitis C treatments, according to a preliminary injunction issued Friday by a federal judge in Seattle. 
 The ruling came in response to a lawsuit filed by state residents who claim the drugs are “medically necessary,” and that the decision by the Washington State Health Care Authority to provide coverage to only the sickest patients had caused them harm.
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Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union

EU regulators also recommended granting marketing approval for Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes on Friday.

Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union

May 27, 2016 07:46 AM Eastern Daylight Time

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients. The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Merck anticipates that the European Commission decision will be made in mid-2016. The company continues to work to achieve manufacturing readiness to supply the EU market, with product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.

“Our application was based on the findings from a broad clinical development program evaluating the efficacy and safety of ZEPATIER across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage 4 or 5 chronic kidney disease.”

The U.S. Food and Drug Administration and Health Canada approved ZEPATIER 50mg/100mg tablets in January 2016. In the United States, ZEPATIER is indicated for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin (RBV).

“We are pleased with the CHMP’s positive opinion recommending the marketing authorization of ZEPATIER in the European Union, which marks an important step forward in the European regulatory process,” said Dr. Roy Baynes, senior vice president and head of clinical development, Merck Research Laboratories. “Our application was based on the findings from a broad clinical development program evaluating the efficacy and safety of ZEPATIER across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage 4 or 5 chronic kidney disease.”

Selected Safety Information about ZEPATIER (elbasvir and grazoprevir)

ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). ZEPATIER is also not for use with organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If ZEPATIER is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen.

Elevations of alanine transaminase (ALT) to greater than 5 times the upper limit of normal (ULN) occurred in 1% of subjects, generally at or after treatment week 8. These late ALT elevations were typically asymptomatic and most resolved with ongoing or completion of therapy. Healthcare professionals should perform hepatic lab testing on patients prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic lab testing should be performed at treatment week 12.

Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces. Healthcare providers should consider discontinuing ZEPATIER if ALT levels remain persistently greater than 10 times ULN. ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalized ratio.

The concomitant use of ZEPATIER with certain drugs may lead to adverse reactions or reduced therapeutic effect due to drug interactions. Certain strong CYP3A inhibitors may increase the plasma concentration of ZEPATIER, leading to possibly clinically significant adverse reactions. Moderate CYP3A inducers may decrease the plasma concentration of ZEPATIER, leading to reduced therapeutic effect and possible development of resistance. Coadministration of ZEPATIER with these drugs is not recommended. Physicians should consult the Prescribing Information for potential drug interactions.

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache and nausea. In subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache.

About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets

ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotype 1 or 4 infection in adults. ZEPATIER is a single tablet taken once daily. The recommended dosing is 12 or 16 weeks with or without RBV, depending on HCV genotype, prior treatment history and, for patients with genotype 1a infection, presence of certain baseline NS5A resistance-associated polymorphisms. See Prescribing Information for ZEPATIER for specific dosage regimens and durations. Refer to RBV prescribing information for RBV dosing and dosage modifications when ZEPATIER is given with RBV. To determine dosage regimen and duration of ZEPATIER for genotype 1a patients, testing for the presence of virus with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, or 93 is recommended prior to initiating treatment.

EU regulators recommend approving Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes

Today The European Medicines Agency (EMA) also recommended granting marketing approval for Mercks ZEPATIER™ (elbasvir and grazoprevir) to treat chronic hepatitis C virus (HCV).

European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

--Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection--

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 27, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Epclusa®, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection. The data included in the application support the use of Epclusa (SOF/VEL) in adults with all genotypes (GT1-6) of HCV infection.

The CHMP positive opinion was adopted following an accelerated review procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

The MAA for Epclusa is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of Epclusa with or without ribavirin (RBV) or 24 weeks of Epclusa. The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy (SVR12).

Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to those who received Epclusa for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively). The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®. The fixed-dose combination of sofosbuvir and ledipasvir received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®.

Gilead has also submitted a regulatory application for SOF/VEL in the United States. Gilead filed the NDA for SOF/VEL on October 28, 2015, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Epclusa is an investigational product and its safety and efficacy has not yet been established.

About Gilead

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that the European Commission or other regulatory agencies, including the FDA, may not approve SOF/VEL for the treatment of chronic hepatitis C and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize SOF/VEL for chronic hepatitis C. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Full European Summary of Product Characteristics for Sovaldi and Harvoni are available from the EMA website at www.ema.europa.eu

- See more at: http://www.gilead.com/news/press-releases/2016/5/european-chmp-adopts-positive-opinion-for-gileads-epclusa-sofosbuvirvelpatasvir-for-the-treatment-of-all-genotypes-of-chronic-hepatitis-c#sthash.sSbput3F.dpuf

Watch Lisa Backus: Examining Efficacy of Hepatitis Medications

Examining Efficacy of Hepatitis Medications

Watch Video
http://www.hcplive.com/conference-coverage/ddw-2016/lisa-backus-examining-efficacy-of-hepatitis-medications

As medications for hepatitis C become more widely used, studies are being done to see how effective these treatments are when used in combination. Speaking at the annual Digestive Disease Week (DDW) 2016 meeting in San Diego, California, Lisa Backus, MD, PhD , from the US Department of Veterans Affairs discussed the results of a recent study looking at some of the more popular medications available on the market. Backus said the study was important because they wanted to see whether the treatments were as effective in real-world practice as they were during clinical trials in the approval process.

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More news from Digestive Disease Week 2016 -: http://www.hcplive.com/conference-coverage/ddw-2016/lisa-backus-examining-efficacy-of-hepatitis-medications#sthash.osApZ4fG.dpuf