You've got a heart attack! AbbVie sub-genre hepatitis C cocktail G/P listing application to FDA

U.S. biotech giant AbbVie recently announced that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the pan-genotype hepatitis C cocktail glecaprevir/pibrentasvir(G/P). G/P(300mg/120mg) is a pan-genotypic hepatitis C cocktail developed for the treatment of all six genotypes of hepatitis C; glecaprevir(G) is an NS3/4A protease inhibitor and pibrentasvir(P) is an NS5A inhibitor. If approved, G/P will provide an 8-week, all-oral, once-daily, ribavirin-free (RBV) regimen for the entire genotypic group of HCV patients without cirrhosis. In October of this year, the FDA has granted G/P breakthrough drug status for the treatment of genotype 1 hepatitis C that has not been cured by direct-acting antivirals (DAAs, including NS5A inhibitors and/or protease inhibitors). In terms of EU regulation, AbbVie has planned to submit a listing authorization application (MAA) for G/P in early 2017.

In the phase III clinical study, the G/P 8-week treatment regimen achieved a very high virological cure rate (SVR12, sustained virological response 12 weeks after completion of treatment) in the population of hepatitis C patients without cirrhosis across all 6 genotypes (GT 1-6). In patients with compensated cirrhosis, the G/P 12-week treatment regimen also achieved a very high virological cure rate. In addition, G/P has also achieved very high cure rates in a patient population with limited therapeutic options, including patients with severe chronic kidney disease (CKD). The G/P 12-week regimen also achieved very high sustained virologic response in a historically difficult-to-treat patient population, including hepatitis C patients who had not previously been cured by direct-acting antivirals (DAAs).

The G/P NDA submission is based on data from eight registry studies in the AbbVie G/P Clinical Development Program, which was conducted in more than 2300 hepatitis C patients in 27 countries. The efficacy and safety of G/P treatment for all six genotypes of hepatitis C, including previously untreated (treatment-naive) and previously treated (treated) patient groups, patients with compensated cirrhosis and those without cirrhosis, a clinically challenging group of refractory patients, such as those with severe chronic kidney disease and those who have not been cured by previous direct-acting antivirals (DAAs).

Previously published data showed that the virological cure rate (SVR12) of the G/P 8-week regimen in the population of patients without cirrhosis and naive genotype 1-6 hepatitis C reached 97.5%(n = 693/711). Data released at the annual meeting of the American Association for the Study of Liver Diseases (AASLD 2016) held in Boston in the middle of last month showed that among genotype 1-6(GT 1-6) hepatitis C patients with severe chronic kidney disease (CKD), intention-to-treat (ITT) analysis showed that the virological cure rate of G/P 12-week regimen reached 98%(n = 102/104); A modified intention-to-treat (mITT) analysis showed a virological cure rate of 100 (n = 102/102) for the G/P 12-week regimen. The mITT excluded patients who failed to achieve SVR for various reasons (except virologic failure). In terms of safety, most treatment-related adverse events were mild or moderate, and the most commonly reported adverse events included pruritus, fatigue, and nausea. Of the 24% of patients who experienced serious adverse events, none were considered to be related to G/P. Four (4%) serious adverse events leading to G/P discontinuation and one death due to a single serious adverse event (intracerebral hemorrhage) after reaching SVR4 were all considered to be unrelated to G/P.

The data released this time are also the latest data of AbbVie G/P clinical development project. The data show that pan-genotype hepatitis C cocktail G/P has high therapeutic effect on all six genotypes of hepatitis C, including patients with severe chronic kidney disease (CKD). At the same time, the therapeutic effect has nothing to do with the previous treatment plan received by patients or whether they are accompanied by compensated cirrhosis.

Hepatitis C has become a worldwide epidemic and is the main cause of end-stage liver disease in Europe, America and Japan. In China, the number of hepatitis C patients has reached 10 million, and continues to grow at a rate of 15%. In such a huge market, but because of the monopoly of patented technology, the most commonly used hepatitis C treatment drug in China is still interferon, which not only has a low cure rate, but also has large side effects. At present, the most common Harvoni, Sovaldi, Viekira, Zepatier, etc. in foreign markets have not yet entered the Chinese market. At present, the acquisition of such drugs depends on purchasing agents. However, compared with purchasing agents from the United States, patients are more willing to purchase from India, because the efficacy of purchasing the same products from India is almost the same, but the price is only 10% of that of the United States. It can be seen that the finished products of these drugs are not very high. It is expected that Chinese companies will complete the application of generic drugs as soon as possible, which will bring benefits to the company and save the lives of thousands of patients.

News source:http://news.bioon.com/article/6695845.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.