Date: 2017-08-03
Type of information: Granting of a Market Authorisation in the US
Product name: Maviret®(EU)/Mavyret®(US)
Compound: glecaprevir/pibrentasvir
Therapeutic area: Infectious diseases
Action mechanism:
- direct-acting antiviral agent/NS3/4A protease inhibitor/nonstructural protein 5A (NS5A) inhibitor. Maviret® is a fixed dose combination of two direct acting-antivirals (DAA), glecaprevir and pibrentasvir.
- Glecaprevir is an inhibitor of the HCV NS3/4A protease, while pibrentasvir is an inhibitor of the HCV NS5A protein.
Company: Abbvie (USA - IL)
Disease: chronic hepatitis C virus (HCV) infection in adults (genotypes 1-6)
Latest news:
- • On August 3, 2017, the FDA approved Mavyret® (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret® is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
- Mavyret® is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more.
- The safety and efficacy of Mavyret® were evaluated during clinical trials enrolling approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 92-100 percent of patients who received Mavyret® for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured. Treatment duration with Mavyret® differs depending on treatment history, viral genotype, and cirrhosis status.
- The most common adverse reactions in patients taking Mavyret® were headache, fatigue and nausea. The drug is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.
- Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret.
- • On June 22, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Maviret®, for the treatment of chronic hepatitis C virus (HCV) infection. Maviret® was reviewed under EMA’s
accelerated assessment programme. The drug will be available as film-coated tablets containing 100 mg glecaprevir and 40 mg pibrentasvir.
- The benefits with Maviret® are that it is highly effective against all genotypes of HCV and can be used in patients with severe renal impairment, including in those on dialysis.
The most common side effects are headache and fatigue.
The full indication is: "Maviret® is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults".
- If approved, Maviret® will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6), who comprise the majority of people living with HCV. The final decision is expected in Q3 2017.
- 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 who are new to treatment, with varied patient and viral characteristics. 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. The type and severity of adverse reactions in patients with cirrhosis were overall comparable to those seen in patients without cirrhosis.
- Maviret® is also intended to be an additional option for patients with specific treatment challenges. This includes 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.
- Maviret® has also been granted accelerated review designations by other regulatory authorities including the FDA and Japanese Ministry of Health, Labour and Welfare.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-08-03
UE authorization: 2017-07-26
Favourable opinion UE: 2017-06-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
