AbbVie Inc (ABBV) Awaits NDA Approval For Hepatitis C Treatment

A New Drug Application (NDA) by AbbVie Inc (NYSE:ABBV) that will be used for the treatment of Hepatitis C is at the mercy the U.S. Food and Drug Administration. Glecaprevir/pibrentasvir (G/P), which will be in direct competition with another treatment from Gilead Sciences, Inc. (NASDAQ:GILD), has been submitted for an investigational pan-genotypic regimen.

The application was supported by encouraging results that had been collected from over 2,300 patients in 27 countries who had used glecaprevir/pibrentasvir (G/P) regimen on trial basis.

The eight weeks of treatment with G/P accomplished high SVR12 rates of 97.5% across all major genotypes of chronic HCV-infected patients. This was notable in patients devoid of cirrhosis and those who are novel to treatment across all major genotypes (GT1-6). High SVR rates were also achieved in patients with limited treatment options the likes of those with severe chronic kidney disease (CKD).

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A Raft Of New Medicines Launched For The Treatment Of Hepatitis C

Earlier, the FDA had granted Breakthrough Therapy designation for G/P Apparently, this comes at a time when AbbVie Inc (NYSE:ABBV) and Gilead Sciences, Inc. (NASDAQ:GILD) are fierce competition, which has propelled the need for new drugs. For example AbbVie’s combination of Viekirax and Exviera, which has recorded more than 90% cure rate in patients with genotype 1 hepatitis C. The combination is challenging Gilead’s Harvoni, which contains sofosbuvir and ledipasvir.

But according to consultant hepatologist at Nottingham University Hospitals NHS Trust, Stephen Ryder, the competition is worth it. He quotes, “These new medicines to treat hepatitis C are a major advance. They have an excellent evidence base for their use, with cure rates of 97% for genotype 1 patients, and even patients with cirrhosis have similarly excellent outcomes.”

AbbVie And Gilead Have External Deals

In the spirit of sustaining competition both AbbVie Inc (NYSE:ABBV) and Gilead Sciences, Inc. (NASDAQ:GILD) have independently closed external deals. AbbVie has done an exclusive deal with Express Scripts in the United States while Gilead has established one with CVS Health Corp (NYSE:CVS).

However, NHS England is of the opinion that the drug companies should be battling over prices with an aim of subsiding them. Charles Grisore, chief executive of the Hepatitis C Trust affirms that there is a demand for prices to be lowered even though pharmaceutical companies are not known to practice this due to fierce competition. Economics bumps up with reality once again. Meanwhile, AbbVie Inc (NYSE:ABBV) was trading at $62.16 for a fall of $0.06 or 0.10% yesterday.

Note: This article is written by Andy Parker and originally published at Market Exclusive.