AbbVie Inc. (ABBV, Financial) has received approval from the U.S. Food and Drug Administration for the commercialization of its Mavyret, according to the organization.
Mavyret is the brand name under which the U.S. global health care company, headquartered in Lake Bluff, Illinois, will commercialize glecaprevir and pibrentasvir, a drug used for the treatment of non-cirrhotic patients who are chronically infected with the genotypes 1-6 of hepatitis C-Virus.
AbbVie’s Mavyret is the first eight-week treatment that has been approved by the U.S. FDA for all the 1-6 known genotypes of the hepatitis C-Virus in non-cirrhotic HCV patients, who are naïve to any treatment for the infection.
The therapy based on Mavyret can also be administered on patients whose liver shows some mild signs of cirrhosis and on those patients who are also affected with a kidney disease, which symptoms range from moderate to severe. The medication can be used even on those HCV patients, who are on dialysis and those who are affected with strain 1 of the hepatitis C-Virus and that have previously undergone an anti- HCV cocktail treatment,also including either NS3/4A protease inhibitor or NS5A inhibitor.
HCV is an infection that affects the liver.
Hepatitis C virus usually spreads through blood contact: people who use intravenous drugs can contract hepatitis if they share needles with someone who already has the virus. The healthcare workers can also contract this infection if they are accidentally stung with a needle that was used on an infected patient.
The incubation period ranges from two weeks to six months; however, 80% of the patients do not show any symptom at this stage. Even in asymptomatic patients, the virus is unfortunately in the liver and causes chronic inflammation. Patients need to be periodically monitored carefully by a doctor, because the disease may also lead to cirrhosis and liver cancer.
The Centers for Disease Control and Prevention (or CDC) estimates that between 2.7 million and 3.9 million people in the U.S. are chronically infected with the hepatitis C-virus.
AbbVie’s application seeking for FDA’s approval of Mavyret was supported by results coming from clinical trials enrolling 2,300 non-cirrhotic adults who were affected with genotypes 1-6 of hepatitis C-virus. The group of enrolled patients also included those whose liver showed some mild signs of cirrhosis. These patients received an eight-, 12- or 16-week treatment with AbbVie’s Mavyret. The results showed that in the blood serum of a percentage ranging between 92 and 100 of these patients the RNA of the hepatitis C virus was undetectable 12 weeks after the treatment.
Besides the Viekira Pak, AbbVie has another drug in its portfolio for the treatment of U.S. people infected with hepatitis C virus following the FDA’s approval for commercialization of Mavyret.
AbbVie is currently trading at $70.99 per share with a market capitalization of $112.98 billion. The stock has gained nearly 13% year to date. It is currently trading with a price-earnings ratio of 17.46, a price-book ratio of 22.65 and a price-sales ratio of 4.40. The forward P/E ratio is 12.90.
Disclosure: I have no positions in any stock mentioned in this article.
