Friday, June 23, 2017 8:54:44 AM
https://finance.yahoo.com/news/enanta-announces-abbvie-receives-chmp-114400217.html
Enanta Pharmaceuticals, Inc. (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted AbbVie a positive opinion recommending marketing authorization of MAVIRET™ (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week treatment option for HCV patients across all genotypes (GT1-6) without cirrhosis and new to treatment, who comprise the majority of people living with HCV.1 The European Commission will now review the CHMP opinion and a final decision is expected in the next quarter. Glecaprevir is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie and is one of the two new direct-acting antivirals (DAAs) combined in MAVIRET.
The CHMP positive opinion is supported by 97.5 percent (n=807/828) SVR12 rates with 8 weeks of MAVIRET across GT1-6 chronic HCV-infected patients without cirrhosis and new to treatment, with varied patient and viral characteristics.2 In an integrated analysis (n=2,265), less than 0.4 percent of patients discontinued treatment.3 The reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.3 The type and severity of adverse reactions in patients with cirrhosis were comparable overall to those seen in patients without cirrhosis.3
“HCV is a global health problem and MAVIRET has the potential to address the majority of patients with a simple 8-week treatment option,” stated Jay R. Luly, Ph.D., President and CEO, Enanta. “We are pleased to have our second protease inhibitor be part of this exciting new HCV regimen.”
MAVIRET is also intended to be an additional option for patients with specific treatment challenges. These include chronic HCV patients with compensated cirrhosis (Child-Pugh A), and those who currently have limited treatment options, such as patients with severe chronic kidney disease, including those on dialysis, and patients infected with genotype 3.
The marketing authorization application (MAA) for MAVIRET is under an accelerated assessment, which is granted by the EMA to new medicines of major public health interest. The MAA evaluation is conducted under the European Union’s centralized licensing procedure, and if approved will result in a marketing authorization valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. It would then be subject to separate reimbursement approvals in each of the member states. AbbVie’s investigational, pan-genotypic combination of glecaprevir/pibrentasvir has also been granted priority review designations by the U.S. Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare. MAVIRET is an investigational regimen and its safety and efficacy have not been established by any regulatory approval.
About MAVIRET™ (glecaprevir/pibrentasvir)
AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) clinical development program was designed to investigate a pan-genotypic, once-daily, ribavirin-free treatment with the potential to provide a faster path to virologic cure** for all major HCV genotypes (GT1-6) and with the goal of addressing specific treatment challenges, including compensated cirrhosis (Child-Pugh A), chronic kidney disease and genotype 3. MAVIRET is being evaluated as a potential 8-week, pan-genotypic treatment for the majority of people living with HCV,1 namely those without cirrhosis and new to treatment,* and regardless of viral and patient characteristics.
MAVIRET is a fixed-dose combination of two distinct antiviral agents: glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.
*Patients who are treatment-naive or had prior treatment experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
Recent ENTA News
- Enanta Pharmaceuticals Announces Data Presentation at ESCMID Global 2024 • Business Wire • 04/17/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:30:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:27:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:23:55 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:19:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:15:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:12:41 PM
- Enanta Pharmaceuticals to Participate at Leerink Partners Global Biopharma Conference • Business Wire • 03/06/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/27/2024 11:31:52 PM
- Form SCHEDULE 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/27/2024 06:11:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:23:37 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:21:41 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:18:12 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:15:48 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:12:54 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:09:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:00:28 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 07:26:49 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/08/2024 09:24:18 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/07/2024 09:05:12 PM
- Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2023 with Webcast and Conference Call Today at 4:30 p.m. ET • Business Wire • 02/07/2024 09:01:00 PM
- Enanta Pharmaceuticals to Participate at the Oppenheimer 34th Annual Healthcare Life Sciences Conference • Business Wire • 02/06/2024 12:00:00 PM
- Enanta Pharmaceuticals to Host Conference Call on February 7 at 4:30 p.m. ET to Discuss its Financial Results for its Fiscal First Quarter Ended December 31, 2023 • Business Wire • 01/31/2024 12:00:00 PM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM